Medical item thermal treatment systems and method of monitoring medical items for compliance with prescribed requirements

ABSTRACT

Various present invention devices enable adherence to requirements for medical items. A medical item of the present invention includes a monitoring or data recording device to monitor and/or record medical solution conditions. The device may further include indicators to indicate compliance of the medical solution with prescribed requirements (e.g., manufacturer, medical standard or regulation, etc.). The medical item may alternatively include a barcode or transponder to uniquely identify the medical item to a thermal treatment system measuring and storing conditions in a central database. The present invention further includes various thermal treatment systems that monitor medical items for prescribed requirements and display the monitored parameters to medical personnel. In addition, the present invention may place time stamp information on medical items to enable determination by medical personnel of compliance with prescribed requirements.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/332,859, entitled “Medical Item Thermal Treatment Systems and Methodof Monitoring Medical Items for Compliance with Prescribed Requirements”and filed Jan. 17, 2006, which is a continuation of U.S. patentapplication Ser. No. 10/805,487, entitled “Medical Item ThermalTreatment Systems and Method of Monitoring Medical Items for Compliancewith Prescribed Requirements” and filed Mar. 22, 2004, now U.S. Pat. No.7,041,941, which is a Continuation-in-Part of U.S. patent applicationSer. Nos.: 09/982,832, entitled “Method and Apparatus for MonitoringTemperature of Intravenously Delivered Fluids and Other Medical Items”and filed Oct. 23, 2001, now U.S. Pat. No. 6,722,782, which is adivisional of U.S. patent application Ser. No. 09/539,183, entitled“Method and Apparatus for Monitoring Temperature of IntravenouslyDelivered Fluids and Other Medical Items” and filed Mar. 30, 2000, nowU.S. Pat. No. 6,467,953, which claims priority from U.S. ProvisionalPatent Application Ser. No. 60/126,874, entitled “Method and Apparatusfor Monitoring Temperature of Intravenously Delivered Fluids” and filedMar. 30, 1999; 10/076,112, entitled “Medical Solution Warming System andMethod of Heating and Maintaining Medical Solutions at DesiredTemperatures” and filed Feb. 15, 2002, now U.S. Pat. No. 6,768,085,which claims priority from U.S. Provisional Patent Application Ser. No.60/301,829, entitled “Medical Solution Warming System and Method ofHeating and Maintaining Medical Solutions at Desired Temperatures” andfiled Jul. 2, 2001; and 10/695,487, entitled “Warming System and Methodfor Heating Various Items Utilized in Surgical Procedures” and filedOct. 29, 2003, which is a continuation of U.S. patent application Ser.No. 10/127,675, entitled “Warming System and Method for Heating VariousItems Utilized in Surgical Procedures” and filed Apr. 23, 2002, now U.S.Pat. No. 6,660,974, which is a continuation-in-part of U.S. patentapplication Ser. No. 09/810,418, entitled “Warming System and Method forHeating Various Items Utilized in Surgical Procedures” and filed Mar.19, 2001, now U.S. Pat. No. 6,376,805, which is a continuation of U.S.patent application Ser. No. 09/413,532, entitled “Warming System andMethod for Heating Various Items Utilized in Surgical Procedures” andfiled Oct. 6, 1999, now U.S. Pat. No. 6,294,762, which is acontinuation-in-part of International Application No. PCT/US98/06951,entitled “Warming System and Method for Heating Various Items Utilizedin Surgical Procedures” and filed Apr. 7, 1998, which claims priorityfrom U.S. Provisional Patent Application Ser. No. 60/042,737, entitled“Warmer Cabinet for Use in Surgical Procedures” and filed Apr. 7, 1997.

In addition, U.S. patent application Ser. No. 10/805,487 claims priorityto U.S. Provisional Patent Application Ser. Nos.: 60/456,394, entitled“Medical Solution Warming System and Method of Heating and MaintainingMedical Solutions at Desired Temperatures with Indications of MedicalSolution Heating Time” and filed Mar. 21, 2003; 60/456,398, entitled“Temperature Control System and Method for Heating Medical Items andProviding Indications of Heating Time” and filed Mar. 21, 2003;60/467,582, entitled “Medical Item Thermal Treatment System and Methodof Monitoring and Reporting Time and Temperature of Thermally TreatedItems” and filed May 5, 2003; 60/472,554, entitled “Method and Apparatusfor Placing Time Stamp Information on Medical Items” and filed May 23,2003; and 60/486,216, entitled “Method and Apparatus for Monitoring andControlling Use of a Medical Item Thermal Treatment System” and filedJul. 11, 2003. The disclosures of the above-mentioned patents and patentapplications are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention pertains to medical item thermal treatment and/ormonitoring systems, such as the types disclosed in U.S. Pat. No.5,408,576 (Bishop); U.S. Pat. No. 6,259,067 (Faries, Jr. et al.); U.S.Pat. No. 6,294,762 (Faries, Jr. et al.); U.S. Pat. No. 6,371,121(Faries, Jr. et al.); U.S. Pat. No. 6,384,380 (Faries, Jr., et al.);U.S. Pat. No. 6,376,805 (Faries, Jr. et al.); U.S. Pat. No. 6,467,953(Faries, Jr. et al.); U.S. Pat. No. 6,566,631 (Faries, Jr. et al.) andU.S. Pat. No. 6,660,974 (Faries, Jr. et al.); U.S. Patent ApplicationPublication Nos.: 2002/0147426 (Faries, Jr. et al.) and 2003/0114795(Faries, Jr. et al.); and U.S. patent application Ser. No. 09/380,507,entitled “Method and Apparatus for Pressure Infusion and TemperatureControl of Infused Liquids” and filed Apr. 24, 2000. The disclosures ofthe foregoing patents, patent publications and patent applications areincorporated herein by reference in their entireties. In particular, thepresent invention is directed toward monitoring intravenous solution orother medical items for compliance with prescribed requirements (e.g.,manufacturer, medical standards or regulations, etc.) from the time thesolution is prepared through disposal of the solution after use in amedical procedure. In other words, the medical solution or other medicalitems are monitored from manufacture at a manufacturing plant, throughtransport and/or storage to an end user or medical facility, throughsubsequent thermal treatment by that user and during administration to apatient. In this manner, a complete record of temperature and/or otherconditions for the medical item is ascertained to determine and/orindicate to medical personnel compliance with the prescribedrequirements.

2. Discussion of Related Art

Various types of medical items require heating to a selected temperatureprior to utilization in a medical procedure. Generally, the medicalitems may be heated for limited time intervals to preserve theireffectiveness. These items typically include intravenous solutions,irrigation fluids, surgical instruments, bottles and blankets.Intravenous (IV) fluids, for example, are typically stored in a coolenvironment and, consequently, require heating to precise temperaturesto prevent thermal shock and injury from occurring during infusion ofthe fluid into a patient. Similarly, irrigation fluids can be warmed orcooled to various temperatures depending upon their intended use. Thesetypes of fluids are typically provided to a patient utilizing a flexiblebag or container filled with the fluid and delivered via a fluid linethat conveys the fluid from the bag to the patient.

Some medical items can only be heated for a limited period of time, orin accordance with controlled warming cycles, in order to avoidadversely affecting their effectiveness. For example, some fluids, suchas whole blood or fluids containing medication, should be warmed evenlyto a specific temperature and can be rendered unusable or unsafe if allor a portion of the fluid is overheated.

In order to provide the necessary heated items for use in medicalprocedures, the related art provides devices for regulating and/ormonitoring temperature of medical items. For example, ovens may bedisposed within operating rooms to heat items to desired temperatures.Further, U.S. Pat. No. 4,419,568 (Van Overloop) discloses a wetdressings heater having a base with side walls defining a cavity, and aninsert connected to the base and defining at least one recess in thecavity for receiving wet dressings. A heater has an electrical heatingelement in close proximity to the insert recess for heating the wetdressings, while the temperature of the heating element is controlled ina desired temperature range for those wet dressings.

U.S. Pat. No. 4,495,402 (Burdick et al.) discloses a warmer for heatingwet dressings and other articles disposed within a heating and storagecompartment. The articles are arranged within the compartment in stackedrelation and disposed on a plate that is supplied with thermal energyfrom a heater. The plate includes a center aperture whereby a firstthermal sensor is disposed in the aperture in contact with a bottom mostarticle. Control circuitry is disposed beneath the plate to control theheater to maintain temperature of the bottom most article at a desiredlevel based on the temperatures sensed by the first thermal sensor and asecond thermal sensor responsive to heater temperature.

U.S. Pat. No. 4,859,360 (Suzuki et al.) discloses a blood bag having atemperature-monitoring device in the form of a tag or label adhered tothe bag outer surface. The temperature-monitoring device includes pluralreversible temperature indicators each associated with a specifictemperature range to indicate a current temperature of the blood, and anirreversible temperature indicator to indicate that the blood hascurrently or previously reached a predetermined temperature. Thereversible indicators individually provide visual indications inresponse to the current blood temperature being within a correspondingrange, while the irreversible indicator maintains a visual indicationonce the predetermined temperature has been reached.

U.S. Pat. No. 5,408,576 (Bishop) discloses an intravenous fluid warmerhaving a cabinet structure to accommodate a plurality of intravenousfluid bags. A temperature sensor and pad of heating filaments aredisposed within the cabinet structure, whereby the temperature sensorenables automatic temperature regulation of the pad of heating filamentsto heat the intravenous fluid bags. The heating filaments are covered bya rubber layer to prevent melting of the bags during heating. Atemperature indicator disposed on the cabinet structure permits a userto ascertain when a desired temperature is attained, whereby anintravenous fluid bag is removed from the intravenous fluid warmer viaan opening defined in a side of the cabinet structure.

U.S. Pat. No. 5,986,239 (Corrigan, III et al.) discloses a conductivewarmer for flexible plastic bags. The warmer includes a heat-conductingmember of thermally conductive material having a plurality of fins whichare parallel and spaced apart to define a plurality of bag-receivingcompartments. The fins are connected to a back portion of theheat-conducting member to which a heating element is attached in aheat-exchanging relationship. The heating element conducts heat throughthe back portion and fins of the heat-conducting member to the bags.

The devices described above suffer from several disadvantages. Inparticular, temperature and heating requirements are typicallyprescribed for medical solutions or other medical items from varioussources (e.g., manufacturer, medical standard or regulation, etc.).These requirements typically prescribe a particular temperature range,expiration date or time and certain time intervals for heating themedical solution in order to maintain the solution efficacy. Theabove-described devices generally do not monitor medical items for orindicate compliance with these prescribed requirements throughout thelife of the medical item (e.g., from manufacture through use anddisposal). For example, the above-described warming devices may providea temperature indication during heating, but do not monitor the heatingtime intervals for the medical items, the medical item temperaturesduring storage or usage outside of the device or the medical itemexpiration date. Although the Suzuki et al. device is secured to andmonitors temperature of a blood bag, there is no manner for that deviceto monitor or indicate the heating intervals and/or passage of theexpiration date or time for the blood bag. Thus, medical personnel mayunknowingly administer to patients solutions and/or medication that areunusable and/or have reduced potency due to non-compliance withprescribed requirements (e.g., an exceeded expiration date, prolongedexposure to heat, attainment of temperatures outside the prescribedrange, etc.), thereby risking serious injury to patients.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to monitor medicalitem conditions and indicate compliance with prescribed requirementsfrom the time the item is prepared through item disposal after use(e.g., throughout the life of the medical item) to prevent use ofcompromised medical items with patients.

It is another object of the present invention to thermally treat medicalitems and monitor medical item conditions (e.g., heating time,temperature, etc.) for, and/or indicate compliance with, prescribedrequirements.

Yet another object of the present invention is to control usage ofthermal treatment systems.

Still another object of the present invention is to monitor medical itemconditions during thermal treatment and generate hardcopy or electronicreports indicating those conditions.

A further object of the present invention is to mark or otherwisetranscribe information associated with a medical item on that medicalitem to notify medical personnel of the medical item status with respectto prescribed requirements.

The aforesaid objects may be achieved individually and/or incombination, and it is not intended that the present invention beconstrued as requiring two or more of the objects to be combined unlessexpressly required by the claims attached hereto.

According to the present invention, various devices enable medicalpersonnel or users to adhere to medical regulatory and medical itemmanufacturer requirements relating to medical item heating time,temperature and/or other conditions in order to ensure patient safety.For example, intravenous (IV) fluid bags are typically heated to precisetemperatures to prevent thermal shock and injury from occurring duringinfusion of the IV fluid into a patient. Generally, the fluid bags maybe heated for limited time intervals to preserve their effectiveness.These time limits may be prescribed by medical standards or regulations,or by the manufacturer of the fluid. A medical solution container orother medical item of the present invention includes a monitoring ordata recording device to monitor and/or record medical solutionconditions. The device may further include indicators to indicatecompliance of the medical solution with prescribed requirements (e.g.,manufacturer, medical standard or regulation, etc.), typicallypertaining to medical solution temperature and heating time intervalssufficient to maintain efficacy of the medical solution. The monitoringdevice may be embedded within or disposed on a container wall or,alternatively, be disposed within the solution, and may utilize awireless communication link to transfer recorded information.

The medical solution container may alternatively include an electronicmemory device attached to or contained within the medical solutioncontainer. The memory device is capable of recording informationreceived from an external device, such as a thermal treatment systemthat has been configured to store warming cycle time, temperature and/orother information in the respective container embedded devices. Thecontainer may further include electronically activated visibleindicators that are triggered based upon compliance with prescribedrequirements.

The medical solution container may alternatively include an externalbarcode or transponder, where the solution container is identified witha unique bar code and/or transponder signal or code that identifies thecontainer to a thermal treatment system measuring medical solutionconditions. The thermal treatment system may transmit event data and/orother information pertaining to the container to a central database.

In another embodiment, the medical solution container may includeelectrochromic ink cells and a control circuit. The control circuitmonitors external and/or internal conditions of the containerenvironment and triggers individual electrochromic cells in response tothe presence of one or more conditions (e.g. max temperature limitexceeded, max humidity exceeded, etc.) to indicate compliance withprescribed requirements. Alternatively, monitoring may be performed byan external unit, such as a thermal treatment system or a box used totransport medical solutions or other sensitive components. In this case,the container includes the electrochromic cells (and, preferably, textidentifying the meaning of each) and a conducting lead to connect thecontainer and corresponding electrochromic cells to the externalmonitoring unit. The unit monitors the container environment andactivates selected electrochromic cells upon the container to cause theelectrochromic cell to change color (e.g., from clear to opaque, etc.)upon determining that allowable conditions have been exceeded. Inaddition, the electrochromic cell on the container may be manuallyactivated by pressing a current source button upon the container tocause the electrochromic cell to change color, thereby allowing a manualover-ride to indicate medical item status with respect to the prescribedrequirements.

The present invention further includes various thermal treatment systemsthat monitor medical solution containers or other medical items forprescribed requirements (e.g., temperature, heating time intervals,etc.) and display the monitored parameters to medical personnel. Thesesystems may be utilized with conventional medical solution containers orthe containers described above to monitor solution conditions. Thethermal treatment systems may be monitored and controlled via aninformation device containing operational parameters. Moreover, thesystems may monitor the time, temperature and/or other conditions ofthermally treated items to generate reports (e.g., printed reports,displays, reports in electronic form, etc.) for users.

In addition, the present invention may place time stamp information onmedical solution containers (e.g., bags or bottles containing saline orintravenous (IV) solutions, antibiotics or other drugs, blood, etc.) orother medical items (e.g., instruments, blankets, etc.) to enabledetermination by medical personnel of compliance with prescribedrequirements (e.g., residence time within a thermal treatment system,the remaining effective or utilization life of the medical solution orother item, etc.).

The above and still further objects, features and advantages of thepresent invention will become apparent upon consideration of thefollowing detailed description of specific embodiments thereof,particularly when taken in conjunction with the accompanying drawings,wherein like reference numerals in the various figures are utilized todesignate like components.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view in perspective of a medical solution containerincluding a monitoring device to monitor solution conditions accordingto the present invention.

FIG. 2 is a schematic block diagram of the monitoring device of FIG. 1.

FIG. 3 is a view in perspective of a medical solution containerincluding a memory device to record and/or indicate solution conditionsaccording to the present invention.

FIG. 4 is a schematic block diagram of the memory device of FIG. 3.

FIG. 5 is a view in perspective of a medical solution containerincluding a bar code serving to identify the medical solution containeraccording to the present invention.

FIG. 6 is a view in perspective of a medical solution containerincluding a transponder unit according to the present invention.

FIG. 7 is schematic block diagram of the transponder unit of FIG. 6.

FIG. 8 is a view in perspective of a medical solution containerincluding electrochromatic cells to indicate solution conditionsaccording to the present invention.

FIG. 9 is a schematic block diagram of a control circuit for theelectrochromatic cells of FIG. 8.

FIG. 10 is a system level block diagram of an exemplary thermaltreatment system that monitors thermally treated items and may generatereports and/or control system usage according to the present invention.

FIG. 11 is a block diagram of the report unit within the system of FIG.10 to generate and/or print reports according to the present invention.

FIGS. 12A-12I are schematic illustrations of exemplary reports producedby the system of FIG. 10 in accordance with the present invention.

FIG. 13 is a block diagram of the usage control unit within the systemof FIG. 10 to control system usage according to the present invention.

FIG. 14 is a diagrammatic illustration of an alternative embodiment ofthe usage control unit of FIG. 13 with a computer system to accessmonitored thermal treatment system information according to the presentinvention.

FIG. 15 is a diagrammatic illustration of yet another embodiment of theusage control unit of FIG. 13 in communication with storage andmonitoring devices via a network according to the present invention.

FIG. 16 is a procedural flow chart illustrating the manner in which amedical item thermal treatment system thermally treats a medical itemand monitors and controls system use according to the present invention.

FIG. 17 is a procedural flow chart illustrating the manner in which thepresent invention enables a user to monitor and control thermaltreatment system use.

FIG. 18 is a view in perspective of an exemplary modular warmer unitaccording to the present invention.

FIG. 19 is a top view in plan of a tray or drawer for the unit of FIG.18 including individual monitoring assemblies and a configuration toenable storage of numerous medical solution containers in a generallyupright position.

FIG. 20 is a view in perspective of an exemplary type of thermaltreatment system for thermally treating and monitoring a medicalsolution within a basin according to the present invention.

FIG. 21 is a view in perspective of an exemplary type of thermaltreatment system for thermally treating and monitoring solution withinan IV line according to the present invention.

FIG. 22 is a view in perspective of a temperature control system forheating medical items and measuring and displaying residence time ofthose items within the system in accordance with the present invention.

FIG. 23 is a front view in elevation of the system of FIG. 22.

FIG. 24 is an exploded perspective view of a drawer of the system ofFIG. 22.

FIG. 25 is a view in elevation of an exemplary heating element of thesystem of FIG. 22.

FIG. 26 is an electrical schematic diagram of an exemplary controlcircuit of the system of FIG. 22.

FIG. 27A is a view in perspective of a temperature control systemincluding guides and a timer according to the present invention.

FIG. 27B is a top view in plan of a limit switch arm employed by thesystem of FIG. 27A.

FIG. 27C is a side view in partial section of the system of FIG. 27A.

FIGS. 28A-28D are views in perspective of exemplary guides of the systemof FIG. 27A.

FIG. 29 is an electrical schematic diagram of an exemplary controlcircuit for the system of FIG. 27A.

FIG. 30 is a view in perspective of a temperature control system forheating plural medical items and measuring and displaying residence timeof those items within the system according to the present invention.

FIGS. 31A-31B are schematic illustrations of exemplary display screensfor the system of FIG. 30 with temperature indications in Celsius andFahrenheit, respectively.

FIG. 32 is an electrical schematic diagram of an exemplary controlcircuit for the system of FIG. 30.

FIG. 33 is an electrical schematic diagram of a heat control circuit ofthe control circuit of FIG. 32.

FIG. 34 is a system flow diagram of an exemplary system for placing timestamp information on medical items and thermally treating those itemsaccording to the present invention.

FIG. 35A is a view in elevation of an exemplary medical item in the formof an intravenous solution bag including time stamp information placedon the bag exterior surface according to the present invention.

FIG. 35B is a view in elevation of an exemplary medical item in the formof an intravenous solution bag disposed within a liner or overwrap,whereby time stamp information is placed on the liner according to thepresent invention.

FIG. 36 is a schematic block diagram of a marking device of the systemof FIG. 34.

FIGS. 37A-37B are schematic illustrations of exemplary labels with timestamp information for placement on a medical item according to thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention enables monitoring of a medical item (e.g.,medical solution containers or bags, etc.) for compliance withprescribed requirements (e.g., manufacturer, medical standard orregulation, etc.) to ensure the medical item maintains efficacy andremains pharmaceutically acceptable. The present invention enablesmonitoring (e.g., continuously and/or at any intervals, etc.) of themedical item at each or any of the stages (e.g., manufacture, transport,storage, thermal treatment, use with patients, etc.) from the time thesolution is prepared through disposal of the solution after use in amedical procedure. In other words, a medical solution or other medicalitems are monitored (e.g., temperature, heating time, age or utilizationlife, etc.) from manufacture at a manufacturing plant, through transportand/or storage to an end user or medical facility, through subsequentthermal treatment by the end user and/or during administration of thesolution to a patient. In this manner, a complete record of temperatureand/or other conditions for the medical item is ascertained to determineand/or indicate to medical personnel compliance with the prescribedrequirements. Thus, the present invention basically enables users toconform to regulatory and medical item manufacturer requirements,typically relating to medical item heating time, utilization life andtemperature, in order to ensure patient safety.

A medical item including a monitoring device according to the presentinvention is illustrated in FIG. 1. Initially, a medical item 2 ispreferably an intravenous solution bag; however, the medical item may beimplemented by a wide variety of medical items (e.g., medical solutioncontainers, saline solutions, IV solutions and/or lines, instruments,blankets, antibiotics or other drugs, blood, irrigation fluid and/orlines, etc.). Specifically, intravenous solution bag 2 is in the form ofa conventional intravenous solution bag and is constructed of plastic orother materials commonly utilized for forming those types of bags. Thesolution bag may contain various types of solutions, such as salinesolution, blood, antibiotic or other drugs, or any other intravenouslyadministered solution. Intravenous solution bag 2 further includes agenerally triangular projection 4 attached to and extending from the bagupper portion. Projection 4 preferably includes a truncated upperportion having an opening or hole 6 defined therein for interfacing anintravenous pole or other support structure (not shown). The bag lowerportion includes an outlet 7 and associated fluid conduits 15 tointerface an intravenous tube (not shown) and enable the solution toflow through the tube from the outlet to a patient.

Generally, intravenous solutions are required to be within a specifictemperature range prior to and/or during infusion to avoid injury to apatient as described above. For example, fluids intravenouslyadministered to a patient have a temperature near the patient bodytemperature, preferably in the approximate range of 86° F.-104° F., andshould not exceed a maximum temperature to maintain solution efficacy.Further, the solutions typically have a prescribed utilization life orexpiration date and heating time in order to maintain their efficacy asdescribed above. The present invention monitors conditions of thesolution bag in order to ensure compliance with the prescribedrequirements (e.g., from the medical item manufacturers, medicalstandard or regulation, etc.). In particular, solution bag 2 furtherincludes a monitoring or data recording device 10. The monitoring deviceincludes or is coupled to sensors 16 (FIG. 2) to monitor the solutionbag from the time the bag is filled with fluid to the process ofdispensing the fluid to the patient. The monitoring device measures andstores information (e.g., age of solution, time, temperature, humidity,heating interval, maximum temperature attained, manufacturing date,expiration date or time, amount or volume of solution, strength ofsolution, diluent, directions, etc.). The measured information may bemeasured either on a periodic basis or in response to an incrementalpositive or negative change in a monitored parameter (e.g., a change intemperature, humidity, etc.).

Monitoring device 10 is typically attached to the interior or exteriorbag surface in a manner enabling the sensors to measure solutionconditions. The monitoring device may be attached to or embedded withinthe bag surface at any desired locations via any conventional or othertechniques (e.g., adhesive, welding, lamination, etc.). For example, themonitoring device may be attached to the bag during bag construction,where a pouch or receptacle (not shown) may be adhered or sealed to thebag interior or exterior surface to receive the monitoring device.Alternatively, the monitoring device may be disposed within the baginterior in a suspended or floating state within the solution. In thiscase, the monitoring device may include any conventional or othersuitable floatation devices to suspend the device within the solution.

The monitoring device may further include a display 12 and/or indicators14 to indicate measured parameters to medical personnel. The display maybe of any shape, size or type (e.g., LED, LCD, etc.), may be disposed atany location on the monitoring device or bag and may display anyinformation. Indicators 14 are preferably implemented by light emittingdiodes (LED) and may indicate to medical personnel conditions and/orcompliance with prescribed requirements. The indicators may be disposedat any locations on the monitoring device or bag and may be activatedbased upon a local assessment of the recorded information or based uponan external assessment of the recorded information by an externalprocessor. In addition, the activation of the indicators may be basedupon local or external assessment of the recorded information withrespect to stored predetermined parameters relating to the prescribedrequirements. The monitoring device further includes an interface 20(FIG. 2) to facilitate communications with an external device 21 asdescribed below and transfer recorded information. The external devicemay be coupled to an external database for storage and retrieval ofinformation.

Referring to FIG. 2, monitoring device 10 includes one or more sensors16, a processor 18 and an interface 20. A power source (not shown),preferably in the form of batteries, provides power to the components.The monitoring device may further include display 12 and/or indicators14 as described above. Processor 18 is typically implemented by aconventional microprocessor and controls operation of the monitoringdevice. However, the processor may alternatively be implemented by anyhardware or circuitry. The processor is coupled to display 12,indicators 14, sensors 16 and interface 20. Sensors 16 are preferablyimplemented by various conventional or other sensors (e.g., proximitysensors, pressure sensors, temperature sensors (e.g., RTD, infrared,etc.), presence sensors, weight sensors, volume sensors, flow sensors,fluid sensors, fluid level sensors, etc.) to measure correspondingconditions (e.g., solution temperature, humidity, fluid level, etc.).The sensors may be disposed in a common monitoring device housing or beexternal of the monitoring device within the solution bag to measure thecorresponding conditions. The measured parameters are provided toprocessor 18, where the processor may record the measured conditions andtime of measurement for storage and/or display. The stored values may bedownloaded to an external device 21 as described below. The monitoringdevice may further record item locations (e.g., manufacturing plant,storage locations, transport, medical facility, etc.) and/or otherinformation to correspond with the time, temperature and/or otherrecordings as described below.

The monitoring device is typically activated at the fluid bagmanufacturing plant. As the bag is being produced, solution temperaturesand/or other conditions are recorded in the processor (or an external)memory. In addition, the monitoring device may store solutioninformation from the manufacturer or other source (e.g., name, strength,amount or volume, expiration date or time, date prepared and diluent,location, directions, etc.). The monitoring device records thetemperature of the solution and/or other conditions as the bag movesfrom the manufacturer, through shipping and storage to the end user ormedical facility. The monitoring device further records solutiontemperature and/or other conditions in the event of thermal treatment ofthe bag by the end user and during administration of solution to thepatient. This provides medical personnel or the medical facility with acomplete record of temperature and/or other conditions for each solutionbag to enable determination of compliance with prescribed requirements(e.g., age, temperature, re-warming, heating intervals, etc.) based onthe information in the record.

The processor may further include information associated with theprescribed requirements (e.g., age, temperature, heating intervals, nore-warming, etc.) and determine compliance with those requirements basedon the measured values. This enables the requirements to beprogrammable, where the monitoring device may be used for any medicalsolutions and/or prescribed requirements. The measured values and/or acompliance indication may be indicated to medical personnel via display12 and/or indicators 14. For example, the processor may control thedisplay to indicate the measured values, prescribed requirements and/oran indication (e.g., message, symbol, etc.) of non-compliance with thoserequirements. The indicators may be of different colors to indicatecompliance (e.g., a green LED), marginal compliance (e.g., a yellow LED)or non-compliance (e.g., a red LED) with any of those requirements(e.g., the indicators may be associated with any quantity of therequirements (e.g., expiration date, temperature, heating interval,re-warming, etc.) to indicate non-compliance with those requirements).Thus, the monitoring device continuously monitors medical items forcompliance with prescribed requirements at each stage of the solutionlife and immediately indicates non-compliance or a compromised solutionto medical personnel.

Interface 20 is coupled to processor 18 and facilitates communicationswith an external device 21 for transfer of information. The interface istypically in the form of a conventional wireless transceiver (e.g., RF,infrared, etc.) to communicate with the external device. The externaldevice may be in the form of a corresponding wirelesstransmitter/receiver (e.g., RF, infrared, etc.) of a processing deviceor system (e.g., computer station or system, hand-held device, etc.).The recorded information in the processor may be downloaded at any timeby the use of the wireless transmitter/receiver. A user positions thesolution bag in close proximity to the wireless transmitter/receiver,where the external device instructs the monitoring device to transmitthe recorded information from memory. Alternatively, the interface maybe in the form of a connector or port for connection to a correspondingport of the external device (e.g., connection to the processing deviceor system) via a cable. The interface receives an instruction from theexternal device and forwards the request to the processor to retrievethe desired information. The processor further controls interface 20 toprovide the information to the requesting device.

The information transmitted to the external device includes raw datathat is processed by the external wireless transmitter/receiver orprocessing system to produce a user friendly format (e.g., a data sheet,a line graph that charts the temperatures over time and location, etc.).The resulting information may be presented on a screen for the user toview, printed for documentation purposes or stored in local or remotedatabase accessible by users or medical personnel.

Location information (e.g., codes for a manufacturer loading dock,hospital receiving or Operating Room, etc.) may be entered into theexternal device by the user (e.g., by keying into the wirelesstransmitter/receiver or processing device the location code) forsubsequent transmission to the monitoring device for storage. Thisenables monitored parameters to be associated with the location of thebag. Alternatively, the monitoring device may further include aconventional Global Positioning System (GPS) transceiver 22 tocommunicate with a GPS satellite to obtain location and/or timeinformation. The transceiver may be implemented by any conventional orother GPS transceiver and is coupled to and controlled by processor 18to retrieve the information for storage.

The external device may further enable entry or provide variousinformation (e.g., start date and start time of solution or other itemheating/cooling, the time interval the solution or other item washeated/cooled, the temperature the solution or other item attainedduring heating/cooling and/or the time and temperature of the solutionor other item when the solution was removed from the system (e.g.,partial or complete history of time and solution or other itemtemperature, facility information (e.g., including name, location,etc.), patient information (e.g., including patient identificationnumber, patient age, patient name, patient sex, patient medications,patient diagnoses, patient commodities and conditions, patient labvalues, patient allergies and sensitivities, patient weight and height,patient pregnancy and lactation status, dosage information, etc.),doctor information, type of procedure, the solution informationdescribed above, type of instruments or other item being heated/cooled,amount or quantity of solution or other item being heated/cooled, etc.)for transmission to and storage in the monitoring device. The externaldevices may be disposed at various locations (e.g., manufacturing plant,transport station, medical facility, etc.) to enable entry and/orretrieval of information. Alternatively, the information may be enteredinto the monitoring device or retrieved for display on display 12 viaprocessor input devices (e.g., keypad, etc.). The monitoring device mayfurther determine and/or indicate various conditions relating to theentered information. For example, a monitoring device equipped withfluid sensors may determine and/or indicate, via display 12 and/orindicators 14, when an appropriate dosage has been administered to apatient. Moreover, the monitoring device may include a uniqueidentifier, where external device 21 may retrieve and store informationfrom the monitoring device in a local or remote central database basedon the identifier for subsequent access by users or medical personnel.This enables information for the particular bag to be retrieved andexamined and/or be utilized for tracking, inventory and/or availabilitypurposes. By way of example, solution bags 2 may communicate withexternal devices disposed at various locations (e.g., manufacturingplant, transport, storage, medical facility, etc.) to enable the bags tobe located or tracked (e.g., via location codes or the GPS). Theinformation may further be stored in a database and accessed todetermine inventory and/or solution availability for the particularlocation. In addition, the monitoring device and/or centrally storedinformation may immediately notify medical personnel of compromisedsolutions (e.g., expired, damaged, contaminated, unsafe, etc.), therebyenabling easy identification and segregation of those compromised itemsuntil proper disposal. The processor and/or interface may utilize anyconventional or other suitable protocol to communicate with and transferinformation with the external device.

In operation, the solution bag is constructed with fluid and appropriateinformation is stored in the monitoring device. The bag is transportedto an intended facility, where the monitoring device continuouslymonitors the solution. Prior to use, medical personnel may view themonitoring device (and/or access the central database) to determinecompliance with prescribed requirements. The monitoring device continuesto monitor the solution and indicate compliance during thermal treatmentand/or administration of solution to a patient. The monitoring devicemay be disposable with the bag or re-programmed for use with subsequentbags.

The monitoring device may further be configured to communicate with athermal treatment system as described below to transfer the recordedinformation. In this case, the thermal treatment system includes thewireless transmitter/receiver or connection port to continuouslycommunicate with interface 20 of the monitoring device as describedabove. The recorded information may be utilized by the thermal treatmentsystem to control heating of the solution bag to a desired set pointtemperature.

A medical item including a memory device to store information pertainingto conditions measured by a thermal treatment system according to thepresent invention is illustrated in FIG. 3. Initially, medical item 2 issubstantially similar to the medical item described above and ispreferably an intravenous solution bag, but may be a wide variety ofmedical items (e.g., medical solution containers, saline solutions, IVsolutions and/or lines, instruments, blankets, antibiotics or otherdrugs, blood, irrigation fluid and/or lines, etc.). Specifically,intravenous solution bag 2 includes a generally triangular projection 4attached to and extending from the bag upper portion and includingopening or hole 6 defined therein as described above for interfacing anintravenous pole or other support structure (not shown). The bag lowerportion includes an outlet 7 and associated fluid conduits 15 tointerface an intravenous tube (not shown) and enable the solution toflow through the tube from the outlet to a patient as described above.

The present invention records conditions of the solution bag measured bya thermal treatment system in order to ensure compliance with theprescribed requirements. In particular, solution bag 2 further includesa memory device 24. The memory device records information received froman external device 21, such as a thermal treatment system treating thesolution bag. The thermal treatment system is configured to measure andtransmit warming cycle, time-temperature and other information (e.g.,start date and start time of solution or other item heating/cooling, thetime interval the solution or other item was heated/cooled, thetemperature the solution or other item attained during heating/coolingand/or the time and temperature of the solution or other item when thesolution was removed from the system (e.g., partial or complete historyof time and solution or other item temperature), the facility, patientand/or solution information described above, doctor information, type ofprocedure, type of instruments or other item being heated/cooled, amountor quantity of solution or other item being heated/cooled, etc.) to thememory device as described below.

Memory device 24 is typically attached to or embedded within the bagsurface and may be disposed at any desired locations via anyconventional or other techniques (e.g., adhesive, welding, lamination,etc.). For example, the monitoring device may be attached to the bagduring bag construction, where a pouch or receptacle (not shown) may beadhered or sealed to the bag interior or exterior surface to receive thememory device. Alternatively, the memory device may be disposed withinthe bag interior in a suspended or floating state within the solution.In this case, the memory device may include any conventional or othersuitable floatation devices to suspend the device within the solution.

The memory device may further include a display 12 and/or indicators 14to indicate measured parameters to medical personnel. The display may beof any shape, size or type (e.g., LED, LCD, etc.), may be disposed atany location on the memory device or bag, and may display anyinformation. Indicators 14 are preferably implemented by light emittingdiodes (LED) and may indicate to medical personnel conditions and/orcompliance with prescribed requirements as described above. Theindicators may be disposed at any locations on the memory device or bagand may be activated based upon a local assessment of the recordedinformation or based upon an external assessment of the recordedinformation by an external processor as described above. For example,the memory device may activate a visible indicator each time a warmingcycle is initiated by a thermal treatment system or trigger a visibleindicator in response to exceeding a pre-determined maximum number ofwarming cycles or heating interval, the solution temperature beingbeyond an acceptable temperature range, re-warming of the bag, etc. Theactivation of the indicators may be based upon various criteria (e.g.,stored logical data and concurrently measured physical data, etc.). Inaddition, the activation of the indicators may be based upon the localor external assessment of the recorded information with respect tostored predetermined parameters relating to the prescribed requirements.The memory device further includes an interface 20 (FIG. 4) tofacilitate communications with a thermal treatment system as describedbelow and receive information.

Referring to FIG. 4, memory device 24 includes processor 18 andinterface 20. A power source (not shown), preferably in the form ofbatteries, provides power to the components. The memory device mayfurther include display 12 and/or indicators 14 as described above.Processor 18 is substantially similar to the processor described aboveand controls operation of the memory device. The processor is coupled todisplay 12, indicators 14 and interface 20. Interface 20 facilitatescommunications with an external device 21 to transfer information. Theexternal device is typically in the form of a thermal treatment systemas described below that treats the solution bag. The thermal treatmentsystem may include various sensors (e.g., proximity sensors, pressuresensors, temperature sensors (e.g., RTD, infrared, etc.), presencesensors, weight sensors, volume sensors, flow sensors, fluid sensors,fluid level sensors, etc.) to measure conditions of the solution (e.g.,temperature, heating intervals, time, humidity, etc.) for transfer tothe memory device. The interface may be in the form of a conventionalwireless transceiver as described above to communicate with a wirelesstransmitter/receiver of the thermal treatment system or, alternatively,may be in the form of a conventional connector to physically connect toa port or connector of the thermal treatment system. The thermaltreatment system receives the solution bag and measures variousconditions or parameters either periodically or in response to changesin conditions (e.g., measures conditions each predetermined timeinterval, in response to changing conditions, etc.). The measuredparameters are transmitted from the thermal treatment system toprocessor 18, where the measured conditions and time of measurement maybe stored in the processor (or an external) memory and/or displayed. Thememory device may further record locations (e.g., medical facility,etc.) and other information (e.g., patient, solution and/or facilityinformation, etc.) received from the thermal treatment system. Thisinformation may correspond with the time, temperature and/or otherrecordings as described above. The location and other information may beentered by a user via system input devices.

The interface may further facilitate communications between the memorydevice and an external device 23 for downloading the recordedinformation to that external device. In this case, external device 23may be in the form of a processing device or system (e.g., computerstation or system, hand-held device, etc.). The recorded information inthe memory device may be downloaded at any time by the use of thewireless transmitter/receiver or physical connector. A user positionsthe solution bag to communicate with the external device (e.g., in closeproximity to the device for a wireless link, in a manner enabling theconnector to engage the external device port or connector, etc.), wherethe external device instructs the memory device to transmit the recordedinformation from memory. The interface receives the instruction andforwards the request to the processor to retrieve the desiredinformation. The processor further controls interface 20 to provide theinformation to the requesting device.

The information transmitted to external device 23 includes raw data thatis processed by the external device to produce a user friendly format(e.g., a data sheet, a line graph that charts the temperatures over timeand location, etc.). The resulting information may be presented on ascreen for the user to view, printed for documentation purposes orstored in a local or remote database accessible by users or medicalpersonnel as described above. The memory device may include a uniqueidentifier to associate the bag with the stored information as describedabove. This enables locating or tracking of bags based on storedlocation information, and ascertaining solution inventory andavailability as described above. The processor and/or interface mayutilize any conventional or other suitable protocol to communicate withand transfer information with the external processing device and thermaltreatment system.

The processor may further include information associated with theprescribed requirements and determine compliance with those requirementsbased on the measured values as described above. This enables therequirements to be programmable, where the memory device may be used forany medical solutions and/or prescribed requirements. The measuredvalues and/or a compliance indication may be indicated to medicalpersonnel via display 12 and/or indicators 14. For example, theprocessor may control the display to indicate the measured values,prescribed requirements and/or an indication (e.g., message, symbol,etc.) of non-compliance with those requirements as described above. Theindicators may be of different colors to indicate compliance (e.g., agreen LED), marginal compliance (e.g., a yellow LED) or non-compliance(e.g., a red LED) with those requirements as described above. The memorydevice may be disposable with the bag or re-programmed for use withsubsequent bags.

The solution bags described above include devices to basically storemeasured conditions and other information for respective solutionswithin those bags. Alternatively, the information for medical items maybe stored based on an item identifier in a central storage unit ordatabase accessible by users or medical personnel. A medical itemincluding an identifier in the form of a bar code is illustrated in FIG.5. Initially, medical item 2 is substantially similar to the medicalitems described above and is preferably an intravenous solution bag, butmay be a wide variety of medical items (e.g., medical solutioncontainers, saline solutions, IV solutions and/or lines, instruments,blankets, antibiotics or other drugs, blood, irrigation fluid and/orlines, etc.). Specifically, intravenous solution bag 2 includes agenerally triangular projection 4 attached to and extending from the bagupper portion and including opening or hole 6 defined therein asdescribed above for interfacing an intravenous pole or other supportstructure (not shown). The bag lower portion includes an outlet 7 andassociated fluid conduits 15 to interface an intravenous tube (notshown) and enable the solution to flow through the tube from the outletto a patient as described above.

Solution bag 2 further includes a bar code 26 disposed on the bag. Thebar code includes a unique identifier associated with the bag toidentify the bag to a thermal treatment system treating the solutionbag. The thermal treatment system is configured to measure and transmitwarming cycle, time-temperature and/or other information (e.g., startdate and start time of solution or other item heating/cooling, the timeinterval the solution or other item was heated/cooled, the temperaturethe solution or other item attained during heating/cooling and/or thetime and temperature of the solution or other item when the solution wasremoved from the system (e.g., partial or complete history of time andsolution or other item temperature), doctor information, type ofprocedure, type of instruments or other item being heated/cooled, amountor quantity of solution or other item being heated/cooled, etc.) to acentral storage unit or database accessible by users or medicalpersonnel as described below. The database may further receive thepatient, solution and/or facility information described above for themedical item (e.g., entered by a user via thermal treatment system inputdevices or a workstation). Bar code 26 is typically attached to orembedded within the bag surface and may be disposed at any desiredlocations on the bag via any conventional or other techniques (e.g.,adhesive, welding, lamination, etc.). For example, the bar code may beattached to the bag during bag construction, where the bar code may beadhered or sealed to the bag interior or exterior surface. The bar codemay be updated and reapplied to the solution bag to provide any desiredadditional information (e.g., requirements, manufacturing date,operational parameters, etc.).

A thermal treatment system receives the bag and includes a bar codereader to ascertain the item identification as described below. Thethermal treatment system may include various sensors (e.g., proximitysensors, pressure sensors, temperature sensors (e.g., RTD, infrared,etc.), presence sensors, weight sensors, volume sensors, flow sensors,fluid sensors, fluid level sensors, etc.) to measure solution conditionsand provides information (e.g., temperature, heating intervals, time,humidity, etc.) for transfer to a central storage unit. The thermaltreatment system measures various conditions or parameters eitherperiodically or in response to changes in conditions (e.g., measuresconditions each predetermined time interval, in response to changingconditions, etc.). The measured parameters are transmitted from thethermal treatment system to a central storage unit to record themeasured conditions and information. A common interface may be employedto permit a wide range of devices (e.g., ranging from thermal treatmentsystems, intelligent storage rooms, workstations, etc.) to reportinformation (e.g., the solution, patient and/or facility informationdescribed above, etc.) related to the treatment of each container (e.g.,with a bar code) to a central database. The thermal treatment system mayfurther record item locations (e.g., medical facility, storage facility,etc.) to correspond with the recorded information as described above.The central storage unit may be local or accessed by the thermaltreatment system via a network as described below. The transferredinformation may be retrieved by users or medical personnel to monitorthe solution bag for compliance with the prescribed requirements.Further, the stored information may be utilized for item tracking,inventory and/or availability purposes as described above.

A medical item including an identifier in the form of a transponder unitaccording to the present invention is illustrated in FIG. 6. Initially,medical item 2 is substantially similar to the medical items describedabove and is preferably an intravenous solution bag, but may be a widevariety of medical items (e.g., medical solution containers, salinesolutions, IV solutions and/or lines, instruments, blankets, antibioticsor other drugs, blood, irrigation fluid and/or lines, etc.).Specifically, intravenous solution bag 2 includes a generally triangularprojection 4 attached to and extending from the bag upper portion andincluding opening or hole 6 defined therein as described above forinterfacing an intravenous pole or other support structure (not shown).The bag lower portion includes an outlet 7 and associated fluid conduits15 to interface an intravenous tube (not shown) and enable the solutionto flow through the tube from the outlet to a patient as describedabove.

Solution bag 2 further includes an identifier in the form of atransponder unit 28. The transponder unit provides a unique identifierassociated with the bag that identifies the bag to a thermal treatmentsystem treating that bag. The thermal treatment system is configured tomeasure and transmit warming cycle, time-temperature and/or otherinformation (e.g., start date and start time of solution or other itemheating/cooling, the time interval the solution or other item washeated/cooled, the temperature the solution or other item attainedduring heating/cooling and/or the time and temperature of the solutionor other item when the solution was removed from the system (e.g.,partial or complete history of time and solution or other itemtemperature), doctor information, type of procedure, type of instrumentsor other item being heated/cooled, amount or quantity of solution orother item being heated/cooled, etc.) to a central storage unit ordatabase accessible by users or medical personnel as described below.The database may further receive the patient, solution and/or facilityinformation described above for the medical item (e.g., entered by auser via thermal treatment system input devices or a workstation). Thetransponder unit may be attached to or embedded within the bag surfaceand may be disposed at any desired locations on the bag via anyconventional or other techniques (e.g., adhesive, welding, lamination,etc.). For example, the transponder unit may be adhered or sealed to thebag interior or exterior surface.

Referring to FIG. 7, transponder unit 28 includes processor 18 and atransceiver 30. A power source (not shown), preferably in the form ofbatteries, provides power to the components. Processor 18 issubstantially similar to the processor described above and controlsoperation of the transponder unit. Transceiver 30 facilitatescommunications with an external device 21 in the form of a thermaltreatment system as described below that treats the solution bag. Thetransceiver may be in the form of a conventional wireless transceiver(e.g., RF, infrared, etc.) to communicate with a corresponding wirelesstransmitter/receiver of the thermal treatment system.

The thermal treatment system receives the bag and includes the wirelesstransmitter/receiver to receive transmissions from the transponder unitto ascertain the item identification. The thermal treatment systemfurther includes various sensors (e.g., proximity sensors, pressuresensors, temperature sensors (e.g., RTD, infrared, etc.), presencesensors, weight sensors, volume sensors, flow sensors, fluid sensors,fluid level sensors, etc.) to measure solution conditions and provideinformation (e.g., temperature, heating intervals, time, humidity, etc.)for transfer to a central storage unit. The thermal treatment systemmeasures various conditions or parameters either periodically or inresponse to changes in conditions (e.g., measures conditions eachpredetermined time interval, in response to changing conditions, etc.).The measured parameters are transmitted from the thermal treatmentsystem to a central storage unit to record the measured conditions andinformation. Alternatively, the transponder unit may receive and storethe measured parameters and other information from the thermal treatmentsystem in the processor (or an external) memory as described above. Acommon interface may be employed to permit a wide range of devices(e.g., ranging from thermal treatment systems, intelligent storagerooms, etc.) to report information (e.g., the solution, patient and/orfacility information described above, etc.) related to the treatment ofeach container (e.g., with a transponder unit) to a central database.The thermal treatment system may further record item locations (e.g.,medical facility, storage facility, etc.) to correspond with therecorded information as described above. The central storage unit may belocal or accessed by the thermal treatment system via a network asdescribed below. The transferred information may be retrieved by usersor medical personnel to monitor the solution bag for compliance with theprescribed requirements. Further, the stored information may be utilizedfor tracking, inventory and/or availability purposes as described above.The transponder unit may be disposable with the bag or re-programmed foruse with subsequent bags.

A medical item including electrochromic ink cells to indicate solutioncompliance with prescribed requirements according to the presentinvention is illustrated in FIG. 8. Initially, medical item 2 issubstantially similar to the medical items described above and ispreferably an intravenous solution bag, but may be a wide variety ofmedical items (e.g., medical solution containers, saline solutions, IVsolutions and/or lines, instruments, blankets, antibiotics or otherdrugs, blood, irrigation fluid and/or lines, etc.). Specifically,intravenous solution bag 2 includes a generally triangular projection 4attached to and extending from the bag upper portion and includingopening or hole 6 defined therein as described above for interfacing anintravenous pole or other support structure (not shown). The bag lowerportion includes an outlet 7 and associated fluid conduits 15 tointerface an intravenous tube (not shown) and enable the solution toflow through the tube from the outlet to a patient as described above.

Solution bag 2 further includes electrochromic ink cells 38 and acontrol circuit 32 that monitors external and/or internal conditions ofthe container environment and triggers individual electrochromic cellsin response to one or more conditions (e.g., max temperature limitexceeded, max humidity exceeded, re-warming, solution expired, etc.) toindicate compliance with prescribed requirements. Examples ofelectrochromic ink cells that may be employed by the present inventionare disclosed in U.S. Pat. No. 6,294,111 (Shacklett, III et al.), thedisclosure of which is incorporated herein by reference in its entirety.The ink cells may be of any quantity, shape or size and may be disposedon a label 36 affixed to the bag. The label may be of any size or shapewith the ink cells being arranged thereon in any fashion. The controlcircuit may include various sensors and triggers an appropriateelectrochromic cell upon conditions specific to the contents of the bagbeing exceeded. One or more cells are associated with a particularcondition (e.g., a particular temperature, humidity, a temperature ortime interval exceeded, passage of an expiration date, re-warming of thebag, etc.) to notify a user or medical personnel of the occurrence ofthat condition. The prescribed requirements may be programmed into thecontrol circuit based upon the specific contents of the bag to allow therequirements to be tailored to the needs of the bag.

The ink cells and/or label may be attached to or embedded within the bagsurface and may be disposed at any desired locations on the bag via anyconventional or other techniques (e.g., adhesive, welding, lamination,etc.). For example, the ink cells and/or label may be adhered or sealedto the bag interior or exterior surface.

Referring to FIG. 9, control circuit 32 includes one or more sensors 16and processor 18. A power source (not shown), preferably in the form ofbatteries, provides power to the components. Processor 18 issubstantially similar to the processor described above and controlsoperation of the control circuit. The processor is coupled to sensors 16and ink cells 38. Sensors 16 are preferably implemented by varioussensors (e.g., proximity sensors, pressure sensors, temperature sensors(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volumesensors, flow sensors, fluid sensors, fluid level sensors, etc.) tomeasure corresponding conditions (e.g., solution temperature, humidity,etc.). The sensors may be disposed within the control circuit or beexternal of the circuit within the solution bag to measure thecorresponding conditions. The measured parameters are provided toprocessor 18, where the processor includes information associated withthe prescribed requirements. The processor determines compliance withthose requirements based on the measured values to activate theappropriate ink cells associated with the condition. The ink cells maybe activated by the processor altering voltage signals provided to thesecells. Activation of the cell produces a color change (e.g., change fromone color to another, clear to opaque, opaque to clear, etc.) toindicate conditions. This enables the requirements to be programmable,where the ink cells and control circuit may be used for any medicalsolutions and/or prescribed requirements. The measured values and/or acompliance indication may be indicated to medical personnel via the inkcells. For example, the processor may control the ink cells to indicatethe measured values, prescribed requirements and/or an indication (e.g.,message, symbol, etc.) of non-compliance with those requirements.

The solution bag may alternatively include the ink cells with thecontrol circuit being disposed within an external device 21. Theexternal device may be in the form of a thermal treatment system or ahousing used to transport medical solutions or other sensitivecomponents. In this case, solution bag 2 includes the electrochromic inkcells (and, preferably, text identifying the meaning of each) and aconducting lead to an external location upon the bag where a remotemonitoring clip 39 can be attached to connect the electrochromic cellsto the external device. The external device monitors the bag environmentand provides control signals to activate selected electrochromic cellson the bag to cause the corresponding electrochromic cell to changecolor (e.g., from clear to opaque, from one color to another, etc.) upondetermining that allowable conditions have been exceeded. This allows auser or medical personnel to view a visible identification mark on thebag indicating that bag contents have exceeded allowed storageconditions and may be compromised.

In addition, solution bag 2 may include one or more current sourcebuttons or switches 34 each associated with a correspondingelectrochromic cell to activate that cell (e.g., change color, etc.) asdescribed above. The buttons provide voltage signals to activate thecorresponding cell in response to actuation and basically serve as amanual over-ride to allow a user or medical personnel to indicate and/oridentify the bag contents as compromised.

The medical items described above enable measurement and/or recordationof medical item conditions from the manufacturing plant throughtransport, storage, thermal treatment and/or administration to apatient. This enables the medical item to be monitored at each or any ofthe stages throughout the life of the medical item and to notify usersor medical personnel of compliance with prescribed requirements. Thermaltreatment systems thermally treating solution bags (e.g., conventionalsolution bags or the bags described above) or other medical items maymonitor and/or record solution conditions for compliance with theprescribed requirements according to the present invention. In addition,the present invention may enable control of thermal treatment systemuse. An exemplary medical item thermal treatment system 100 to monitorand/or record medical item conditions and/or employing usage controlaccording to the present invention is illustrated in FIG. 10. The systemmay thermally treat a wide variety of medical items (e.g., medicalsolution containers, saline solutions, IV solutions and/or lines,instruments, blankets, antibiotics or other drugs, blood, irrigationfluid and/or lines, etc.). Specifically, system 100 may be of any of thetypes of thermal treatment systems disclosed in the aforementionedpatents, patent publications and patent applications and includes atemperature controller 102, one or more heating/cooling units 104 andone or more monitoring sensors 106 associated with each heating/coolingunit. The heating/cooling units (and/or corresponding sensors) areassociated with a corresponding individual medical item or a systemcompartment receiving medical items to be treated. The system mayfurther include a report unit 101 and a usage control unit 1001. Thereport unit facilitates collection of measured information to generate areport, while the usage control unit enables control of system operationas described below.

Temperature controller 102 may be implemented by any conventional orother controller or microprocessor (e.g., chip, card, processor,circuitry, etc.) and controls heating/cooling units 104 to thermallytreat a corresponding system compartment and/or medical item to adesired temperature. Monitoring sensors 106 are disposed in theproximity of a corresponding heating/cooling unit 104 or medical item todetect various conditions (e.g., the insertion, presence and/or removalof a medical item within the system, the medical item and/orheating/cooling unit temperature, etc.). Monitoring sensors 106 may beimplemented by any conventional or other sensors (e.g., proximitysensors, pressure sensors, temperature sensors (e.g., RTD, infrared,etc.), presence sensors, weight sensors, volume sensors, flow sensors,fluid sensors, fluid level sensors, etc.) to measure and provide anyinformation, and are coupled to temperature controller 102. Thetemperature controller and/or monitoring sensors may be further coupledto report unit 101 and/or usage control unit 1001.

Temperature controller 102 typically includes input devices (not shown)to receive a desired or set point temperature for each medical itemand/or system compartment from a user and a display (not shown) todisplay the desired and/or measured temperatures for each medical itemand/or compartment. The temperature controller compares the set pointtemperature for a medical item and/or compartment to the correspondingmeasured temperature and controls the associated heating/cooling unitaccordingly to maintain the medical item and/or compartment at or nearthe desired temperature. For example, the temperature controller maydisable heating (or enable cooling) in response to a measuredtemperature exceeding a desired temperature. Conversely, the temperaturecontroller may enable heating (or disable cooling) in response to ameasured temperature below a desired temperature. Heating/cooling units104 may be implemented by any conventional or other heating and/orcooling devices (e.g., heating pad or coils, refrigeration coils,thermoelectric device, etc.).

Referring to FIG. 11, report unit 101 includes a report controller 108,interface 20, a printer 110, memory storage 112, a display 114 and/or atimer 120. The system includes devices to measure, record and/or providea report (e.g., hardcopy or electronic form) of system conditions (e.g.,time, date, temperature, fluid loss or removal, etc.) as describedbelow. The report provides medical personnel documentation for theirfiles on the heating/cooling characteristics. The primary informationproduced is the start date and start time of solution or other itemheating/cooling, the time interval the solution or other item washeated/cooled, the temperature the solution or other item attainedduring heating/cooling and/or the time and temperature of the solutionor other item when the solution was removed from the system (e.g.,partial or complete history of time and solution or other itemtemperature). The report may further include a variety of information(e.g., doctor information, type of procedure, type of instruments orother item being heated/cooled, amount or quantity of solution or otheritem being heated/cooled, etc.). Specifically, report controller 108 iscoupled to temperature controller 102 and receives various information(e.g., enablement/disablement of units 104, temperature, etc.) relatedto thermal treatment of the medical item. The report controller mayreceive any additional information (e.g., the facility, patient and/orsolution information described above, doctor information, etc.) frommedical personnel or users via report controller input devices (notshown). The report controller may be implemented by any conventional orother controller or microprocessor (e.g., chip, card, processor,circuitry, etc.). Alternatively, the temperature controller and reportcontroller may be implemented by a single controller (e.g., temperaturecontroller 102).

The report controller further maintains the date, elapsedheating/cooling time and occurrence time of an event or condition (e.g.,the time when medical items are inserted and/or removed from the system,etc.). The time may be measured and/or displayed by the reportcontroller or by timer 120 as described below. The report controller maymeasure the elapsed time or record an occurrence time based on signalsreceived from the temperature controller and/or input devices. Forexample, the report controller may initiate measurement of a timeinterval in response to the temperature controller indicating enablementof heating/cooling units 104, and may store the elapsed and/oroccurrence time in response to any condition (e.g., when solution orother item is removed). The report controller may further measureelapsed time or record elapsed and/or occurrence time in response tomedical personnel manually entering information on the report controllerinput devices (e.g., start and stop keys). The report controllercollects the appropriate information and arranges the information into areport. The report may be arranged in any fashion and include anydesired information. The report controller may further providecorresponding information to solution bag 2 via interface 20 asdescribed above. The interface may be in the form of a wirelesstransmitter/receiver (e.g., RF, infrared, etc.) or a connector or portto communicate with the solution bag as described above. Alternatively,the interface may be in the form of a bar code reader to identify aparticular medical item and enable the report controller to transmitcorresponding information to a central database for review, tracking,inventory and/or availability purposes as described above. Moreover, thereport and/or information may be stored in a memory device (e.g., localmemory, removable memory, card, disk, etc.) for later retrieval asdescribed below. In addition, the report controller and/or timer arecoupled to display 114 to display the elapsed (or running) time, reportor any desired information to medical personnel. The informationdisplayed may be selected via report controller input devices, or thedisplay may include display controls (e.g., buttons, keys, etc.). Thereport may further be printed by the report controller via printer 110.The printer, timer and display may be implemented by any conventional orother printer, timing and/or display devices.

A memory storage device 112 is coupled to report controller 108 and isused to store the collected information. Basically, the reportcontroller logs records containing system information (e.g., thedate/time that a medical item is inserted into system 100, the date/timethat the medical item is removed from the system, temperatures, etc.).In this manner, use of the medical item warming/cooling system isdocumented with recorded log entries. Log triggering events can be userdefined via report controller input devices that allow the system to beconfigured to record information in response to a wide variety ofdetected conditions and/or at particular times or periodic intervals.The memory storage can be used to store a wide variety of informationrelated to use of the system and the thermal treatment of individualmedical items and can be any type of storage media. For example, memorystorage device 112 can include, but is not limited to, an electronicmemory chip, a smart card, a floppy disk, a fixed or removable magneticdisk. The report controller may be configured to support one or more ofthose memory storage types.

The system may record information regarding each medical item placed inthe system. The information collected and/or recorded by the reportcontroller and/or produced in a report can include, but is not limitedto: the date/time that a medical item was placed into/removed from themedical item warming/cooling system, the temperature of the medical itemupon being placed into/removed from the medical item warming/coolingsystem, the temperature of the medical item at specific points in timewhile stored in the medical item warming/cooling system, start date andtime that the medical item began to be heated/cooled, the length of timethat the medical item was heated/cooled, the temperature that themedical item was heated/cooled to during the heating/cooling cycleand/or the amount of solution or other item residing, placed in orremoved from the system. The report may also include relatedinformation, such as patient information (e.g., name, identificationnumber and/or the other patient information described above), facilityinformation (e.g., name, location and/or the other facility informationdescribed above), doctor information, the type of procedure, thesolution information described above, the type of item beingheated/cooled, the amount or quantity of fluid or other item beingheated/cooled (e.g., fluid (or other item) level, volume or weight), theflow rate of fluid that is being heated/cooled, the pressure of fluidflow as the fluid is heated/cooled and any other desired information.The thermal treatment system may employ any type of sensors or sensingdevices (e.g., temperature sensors, presence sensors, weight sensors,volume sensors, pressure sensors, flow sensors, fluid sensors, fluidlevel sensors, etc.) as described above to measure and provide anydesired information to the report controller for inclusion in a report.The recordation or collection may occur automatically or via userentered information (e.g., start, stop and/or record keys) as describedabove.

Report controller 108 stores and retrieves information from memorystorage 112 in order to produce a report with any desired information.The report may be transmitted to printer device 110 that may beintegrated within medical warming/cooling system 100. The report mayfurther be displayed by the report controller on display 114. Theprinter basically provides a report in hardcopy form. The reportcontroller may control the printer to produce the report at specifiedtimes (e.g., termination of heating/cooling, at particular times of day,after a particular quantity of uses, etc.) or in response to requestsfrom medical personnel via report controller input devices (e.g., printkey). The printer may print the report on any desired hardcopy medium.Preferably, the printer places the information onto a label that may beattached to a medical file and/or to the medical item. The informationmay be printed during or after the item heating/cooling, or be stored ona memory device and printed at a desired time as described above. Theprinter may further provide additional copies of the report in responseto user requests, or a medium automatically creating duplicates may beutilized (e.g., carbon-less paper, etc.).

The report or other information may alternatively be provided inelectronic form. The report controller may facilitate communication withother devices for transference or downloading of the report or otherinformation to those devices. For example, the information may bedownloaded or transmitted over a network or other communications mediumto another device (e.g., PDA, computer, another thermal treatmentsystem, etc.) for viewing, storage and/or printing. Further, the reportcontroller may transmit the report or other information to solution bag2 via interface 20 or identify the solution bag or other medical itemvia an identifier (e.g., bar code or transponder) and transfercorresponding information to a central database as described above. Anexternally attached device can be connected to warming/cooling system100 via a direct local connection or via a network connection. Networkconnections to report controller 108 can include any combination ofcable-based or radio-based local area network (LAN), wide area network(WAN), or Internet network links. The external local device or networkconnection can use a cable-based or radio-based connection to a port, ornetwork card, on system 100. Moreover, the report controller mayfacilitate retrieval of information (e.g., the patient, facility and/orsolution information described above, doctor information, item (e.g.,instrument, etc.) information, etc.) from a database, network or othersource for the report.

Report controller 108 is capable of transmitting generated reports orany desired information to internally mounted printer 110, a locallyconnected external printer 204, a locally connected personal digitalassistant (PDA) 206 and/or a locally connected computer workstation 208(e.g., including or coupled to the central database storing medical iteminformation). Further, report controller 108 is capable of transmittinggenerated reports via a LAN/WAN/Internet network 210 to remotelyconnected devices, such as a network connected printer 212 and/or anetwork connected computer workstation 214 (e.g., including or coupledto the central database for storing medical item information). Inaddition, plural systems 100 may be coupled to a network to enable aworkstation to access the system reports or medical item informationremotely (e.g., via a LAN, Internet server or website, etc.) to enablemonitoring of medical item compliance with prescribed requirements.

Information is collected by report controller 108 and stored in memorystorage 112, typically in real-time, as events occur. Reports or medicalitem information can be generated and printed/displayed or transmitted(e.g., to the medical item, external devices or databases, etc.) in atimely manner to allow a local or remote (e.g., at network workstationor computer 214) user to monitor the status of one or more systems andthe status of medical items undergoing thermal treatment. Alternatively,reports or other information can be generated and printed/displayed ortransmitted at a time of a user choosing. For example, a user eitherlocal to or remote from a system is able to monitor the temperature ofmedical items and the time that medical items have been stored within amedical item warming/cooling system based upon reports printed or shownon a display device. The user may access stored information relating toone or more medical item warming/cooling systems 100 by requesting(e.g., via report controller input devices, a remote workstation, etc.)that a report be produced or displayed to a specific printer or display(e.g., local or remote). Further, the information stored by the medicalitem or solution bag 2 may be downloaded to an external device asdescribed above to monitor conditions.

The present invention generates and/or transmits reports to a display,printer, medical item or external device based upon concurrentlymonitored information, or based upon information stored within a memorystorage device. The printed reports or transmitted information create apermanent log record that documents events that occur within the medicalitem warming/cooling system. Thus, a valuable, previously unavailablesource of historical information is available to doctors, nurses,technicians, and hospital staff for use in support of patient recordkeeping, compliance with medical standards, scheduling routinemaintenance, detecting malfunctioning devices, assessing costs to aspecific operating team or medical patient, and adjusting the number andtypes of medical item warming/cooling systems to meet demand based uponactual use. The reports or information may be generated, displayed,transmitted and/or printed at particular times or concurrently withsystem operation (e.g., as information is measured and/or collected) toprovide current system information (e.g., the printouts and/or displaysmay be updated continuously with report information).

An exemplary report of information that may be produced by reportcontroller 108 and transmitted to and/or printed or displayed on locallyor remotely connected devices (e.g., display, medical item, printer,etc.) is illustrated in FIG. 12A. The report can include a wide varietyof information. Exemplary report information may include medical itemwarming/cooling data 302 (e.g., type of item/fluid, intended use, startdate, start time, duration, start temperature, removal temperature,fluid flow pressure (if applicable) and/or the other solutioninformation described above). Other exemplary report information mayinclude patient information 304 (e.g., patient name, patient id#, bloodtype and/or the other patient information described above),warming/cooling system information 306 (e.g., warming/cooling system ID,warming/cooling chamber ID, warming/cooling system serial number,manufacturer's number, last inspected date, inspected by and nextinspection date), facility information 308 (e.g., facility name,facility location, doctor's information, type of procedure and/or theother facility information described above) and report metadata 310(e.g., data collected date/time, report generation date/time andoperating technician).

The report controller may provide any desired information (or anyportions of the information to provide a more consolidated report)arranged in any fashion. For example, the report or transmittedinformation can include only a system ID number and select itemwarming/cooling data. The report can be adapted to display a widevariety of information that addresses a wide variety of warming/coolingsystem configurations. Further, generated reports will vary dependingupon the configuration and use of the respective medical itemwarming/cooling systems and the information desired for a medical item.The information can be displayed locally or upon any printer/displayconnected to the medical item warming/cooling system. Further,information stored in a medical item may be downloaded as describedabove.

Alternative exemplary reports are illustrated in FIGS. 12B-12I. Thereports of FIGS. 12B-12C include the date (e.g., month, day year(MM/DD/YY) or any other desired format), current time (e.g., hours andminutes (HH:MM) or any other desired format), start and end time (e.g.,hours and minutes or any other desired format) of item heating/coolingand item temperatures at various points in time. The item temperaturesare arranged, by way of example only, in a columnar format. The timesmay be at any desired periodic intervals or in response to a particularcondition. For example, reports for IV solution warming (e.g., FIGS. 18,21, 22, 27A and 30) or open basin (e.g., FIG. 20) type systems mayindicate the temperature of solution or solution containers measured atany desired time interval (e.g., fifteen minutes, two minutes, oneminute, etc.). Alternatively, reports for an open basin type system(e.g., FIG. 20) may indicate the time and temperature of solution whenthe solution is removed or scooped from the basin. These reports mayfurther indicate the amount of solution residing, placed in and/orremoved or scooped from the basin.

The reports of FIGS. 12D-12I generally provide time and temperatureinformation in graphical form. In particular, these reports include thedate (e.g., month, day year (MM/DD/YY) or any other desired format),current time (e.g., hours and minutes (HH:MM) or any other desiredformat) and graphs showing solution or other item temperature inrelation to time. The graphs include an abscissa or ‘X’ axis associatedwith time and an ordinate or ‘Y’ axis associated with temperature. Thetime axis may extend for several hours (e.g., FIGS. 12D and 12F-12H) orfor a particular time interval or time of day (e.g., FIGS. 12E and 12I).A series of temperature symbols (e.g., dots) are placed on the graph toindicate the temperature of solution or other item at a given time(e.g., FIGS. 12D and 12F). The temperature symbols may be connected byor reside on a line (e.g., FIG. 12G), or the line may be utilized(without the temperature symbols) to provide a continuous report of timeand temperature (e.g., FIGS. 12E, 12H and 12I). In addition, a removalsymbol (e.g., diamond) may reside in the line (e.g., FIGS. 12E, 12G-12I)or series of temperature symbols (e.g., FIGS. 12D and 12F) to indicatetimes when solution or other items are removed. The time of removal maybe indicated by reference lines extending from the removal symbols tothe time axis (e.g., FIG. 12H), or by placing the actual removal time(e.g., in hours and minutes (HH:MM) or any other desired format)proximate the removal symbol (e.g., FIG. 12I). These reports aretypically utilized by open basin type systems (e.g., FIG. 20), where thereports may further indicate the amount of solution residing, placed inand/or removed or scooped from the basin. However, the reports may beutilized by any types of medical item thermal treatment systems, such asthose disclosed in the aforementioned patents, patent publications andpatent applications. The reports described above may be printed,transmitted and/or displayed at particular times or continuously andupdated as data is collected (e.g., the graphs and/or columns may beupdated with information as time progresses, etc.). The continuousreports are generally utilized for IV warming type systems and medicalitems (e.g., bag or line warmers, medical items, solution bags, etc.) toprovide a continuous printout, display or history of item temperature,but may be utilized with any medical item thermal treatment system.

Usage control unit 1001 enables control of thermal treatment system use.Referring to FIG. 13, usage control unit 1001 includes an informationdevice system interface 1008, an information device 1010 with storage ormemory 1012, display 114 and/or timer 120.

Information device 1010 is preferably in the form of a chip orintegrated circuit, but may be implemented by any type of deviceincluding a memory or storage (e.g., a microprocessor with memory, achip, a floppy, magnetic or optical disk, CD-ROM, USB disk, smart card,etc.). The information device (e.g., chip) is typically provided to auser by a system service provider for installation in the thermaltreatment system. Basically, the user plugs the information device intoa receptacle on or within the system to couple the information device tosystem interface 1008. However, the coupling between the systeminterface and information device may be accomplished in any fashion(e.g., direct connection, infrared, RF transmission, cellular,Bluetooth, etc.). The system interface collects information fromtemperature controller 102 and/or monitoring sensors 106 during systemoperation and stores the collected information on information device1010, preferably in storage device or memory 1012. The system interfacemay be implemented by any conventional or other device (e.g.,microprocessor, controller, processing system, chip, circuitry,read/write unit, etc.) capable of collecting information andtransferring data with information device 1010 and/or storage 1012.

The system interface is preferably disposed within the thermal treatmentsystem; however, the interface may be disposed external of the thermaltreatment system and coupled to the system via any desired medium (e.g.,cable, wireless, etc.). The system interface may further maintain thedate, elapsed heating/cooling time and/or occurrence time of an event orcondition (e.g., the time when medical items are inserted and/or removedfrom the system, etc.). The system interface may measure the elapsedtime or record an occurrence time based on signals received from thetemperature controller, monitoring sensors and/or system interface inputdevices. For example, the system interface may initiate measurement of atime interval in response to the temperature controller indicatingenablement of heating/cooling units 104, and may store the elapsedand/or occurrence time in response to any condition (e.g., when solutionor other item is removed). The system interface may further measureelapsed time or record elapsed and/or occurrence time in response tomedical personnel manually entering information on the system interfaceinput devices (e.g., start and stop keys). Alternatively, timer 120 maymaintain elapsed time and provide timing information to the systeminterface and/or display.

The system interface collects the appropriate information and arrangesthe information for storage in memory 1012. The collected informationmay be arranged in any fashion and include any desired information. Thesystem interface may collect and store a wide variety of information instorage 1012 related to the use of the thermal treatment system and thewarming/cooling of individual medical items. For example, informationpertaining to each medical item may be individually recorded andinclude: the date/time that a medical item was placed into/removed fromthe medical item warming/cooling system, the temperature of the medicalitem upon being placed into/removed from the medical itemwarming/cooling system, the temperature of the medical item at specificpoints in time while stored in the medical item warming/cooling system,start date and time that the medical item began to be heated/cooled, thelength of time that the medical item was heated/cooled, the temperaturethat the medical item was heated/cooled to during the heating/coolingcycle and/or the amount of solution or other item residing, placed in orremoved from the system.

The system interface may also store related information in memory 1012,such as patient information (e.g., name, identification number and/orthe other patient information described above), thermal treatment systeminformation (e.g., type, identification or serial number, etc.), userinformation (e.g., access or account identification or code, passwords,etc.), facility information (e.g., name, location and/or the otherpatient information described above), doctor information, the type ofprocedure, the solution information described above, the type ofsolution or other item being heated/cooled, the amount or quantity offluid or other item being heated/cooled (e.g., fluid (or other item)level, volume or weight), the flow rate of fluid that is beingheated/cooled, the pressure of fluid flow as the fluid is heated/cooledand any other desired information. The thermal treatment system mayemploy any type of sensors or sensing devices (e.g., temperaturesensors, presence sensors, weight sensors, volume sensors, pressuresensors, flow sensors, fluid sensors, fluid level sensors, etc.) tomeasure and provide any desired information to the system interface forinclusion on information device 1010. The related information (e.g.,user, system, facility, patient and/or doctor information, etc.) may bepre-stored on the information device and/or entered by a user via systemor interface input devices (e.g., keypad, etc.). The recordation orcollection of information by the system interface may occurautomatically or via user entered information (e.g., start, stop and/orrecord keys) as described above. In this manner, storage 1012 is used todocument use of the medical item thermal treatment system with recordedlog entries. Logged event data may be user defined and/or pre-configuredand may be generated in accordance with a periodic schedule and/or inresponse to a wide variety of events.

Generally, the information stored by the system interface in storage1012 depends upon the particular type of thermal treatment system andcorresponding sensors employed. For example, information collected andstored for IV solution warming (e.g., FIGS. 18, 21, 22, 27A and 30) oropen basin (e.g., FIG. 20) type systems may include the temperature ofsolution or solution containers measured at any desired time interval(e.g., fifteen minutes, two minutes, one minute, etc.). Alternatively,the information stored for an open basin type system (e.g., FIG. 20) mayinclude the time and temperature of solution when the solution isremoved or scooped from the basin. The stored information may furtherindicate the amount of solution residing, placed in and/or removed orscooped from the basin.

The stored information may be retrieved or downloaded from informationdevice 1010 and printed to generate a hardcopy report of thermaltreatment system activity as described below. The report preferablybecomes the permanent record of the thermal treatment system for laterreview. Further, the information from storage 1012 may be uploaded toone or more other storage devices as part of a permanent archive.

System interface 1008 may further retrieve usage and control parametersfrom memory 1012 and coordinate with temperature controller 102 tocontrol operation of medical item thermal treatment system 100 inaccordance with the retrieved parameters. The usage and controlparameters are typically stored on information device 1010 by theservice provider and may include: a calendar/time period during whichthe medical item thermal treatment system is authorized for use; anumber of warming/cooling cycles for which the medical item thermaltreatment system is authorized for use; a number of medical items forwhich the medical item thermal treatment system is authorized for use;type of use (e.g., heating, cooling, heating and cooling, etc.); a useraccess code; type of medical item accepted; a desired temperature formedical items; a maximum duration that a medical item (e.g., IV solution, blood, etc.) is allowed to remain in the thermal treatment system;time and/or temperature thresholds to be used in controlling alarms; logevent definitions; timeouts; timer periods; various threshold values;log messages; storage destinations; etc.

The usage parameters enable a user to lease or rent use of the thermaltreatment system based on various metrics (e.g., quantity ofheating/cooling cycles, quantity of blocks or intervals of time,quantity of medical items, etc.). For example, usage parametersretrieved from storage 1012 may enable use of a medical item thermaltreatment system for a specific number of warming/cooling thermaltreatment cycles or for a particular time duration. Prior to initiatingan activity (e.g., a heating/cooling cycle for a medical item),temperature controller 102 communicates with system interface 1008 torequest authorization to initiate the activity. The authorizationrequest typically includes a description of the type of activity (e.g.,a heating/cooling cycle) and other relevant information (e.g., theheating/cooling unit to be used) for which verification of authorizeduse is requested. Upon receipt of the authorization request, systeminterface 1008 checks usage parameters stored in storage 1012 todetermine whether the requested activity can be performed. If the usageparameters indicate the requested activity may be performed (e.g.,sufficient quantity of cycles or time intervals exist), system interface1008 enables temperature controller 102 to perform the activity (e.g.,provides control signals to enable the temperature controller).Otherwise, if the usage parameters indicate the requested activity maynot be performed, system interface 1008 disables temperature controller102 (e.g., provides control signals to disable the temperaturecontroller).

The usage parameters are updated in accordance with system use tocontrol usage of the system. For example, the quantity of cycles or timeinterval stored on the information device may be updated (e.g.,incremented or decremented) to indicate remaining system usage enabledby the information device. The system typically includes a display 114coupled to the system interface that displays the remaining amount ofsystem usage indicated by the usage parameters stored on the informationdevice (e.g., remaining time or quantity of cycles). Upon exhausting theamount of use authorized by the usage parameters, the display notifiesan operator that a new information device (e.g., chip) is needed. Thismay be accomplished by audio and/or visual indicators (not shown). Theuser orders a new information device from the service provider andremoves the current information device for forwarding to the serviceprovider. The data stored on the information device is retrieved andprocessed by the service provider to generate reports of system activityfor the user (e.g., in various forms, such as hardcopy, e-mail, storagemedia (e.g., CD-ROM, floppy, etc.), fax, etc.). The retrievedinformation may also be stored for later retrieval. The informationdevice may be re-programmed by the service provider to enable use of athermal treatment system in accordance with the revised usage andcontrol parameters on the information device as described above

In operation, a service provider provides a user with information device1010, preferably in the form of a chip. The information device (e.g.,chip) is pre-programmed with usage and/or control parameters to controloperation and usage of the thermal treatment system as described above.The user installs the information device on or in the thermal treatmentsystem, where the information device is coupled to system interface1008. Medical items are inserted into the thermal treatment system,where the user operates the system to thermally treat the items. Thesystem interface retrieves the appropriate parameters from theinformation device and controls the temperature controller accordinglyas described above. The remaining usage authorized by the informationdevice is typically displayed on display 114 as described above.

During thermal treatment of the items, the usage parameters and displayare updated. Further, system interface 1008 collects various informationfrom temperature controller 102 and/or sensors 106 and stores thisinformation on information device 1010. When sufficient information hasbeen stored on information device 1010 or other condition occurs (e.g.,expiration of usage, completion of system activity, etc.), theinformation device is removed from the system and forwarded to theservice provider. The service provider retrieves and processes thecollected information to generate reports for the user and re-programsthe information device (e.g., revises the usage parameters) foradditional use as described above. Alternatively, collected informationmay be formed into reports (e.g., FIGS. 12A-12I) by report unit 101 asdescribed above, where the reports or information can be transmitted tointernal printer 110, display 114 or to a local or remote externaldevice (e.g., printer, display, database, medical item, etc.) asdescribed above.

An alternative embodiment of usage control unit 1001 employing acomputer system to access collected information on the informationdevice is illustrated in FIG. 14. Specifically, usage control unit 1001is substantially similar to the unit described above and includesinformation device system interface 1008, display 114 and/or timer 120.Information device 1010 is in the form of a “smart” card and includesstorage 1012. The card typically includes a plastic or paper substratethat houses storage 1012 and accompanying components (e.g., processor,circuitry, etc.). System interface 1008 is substantially similar to thesystem interface described above and transfers information withinformation device 1010. The information device (e.g., card) is sent toa user, preferably once, by a service provider with usage and controlparameters stored thereon. The information device is received by thethermal treatment system and coupled to the system interface asdescribed above, where the system functions as described above tocollect information and store the information on information device1010. Further, the system interface controls operation and use of thesystem in accordance with the usage and control parameters as describedabove.

When sufficient information has been stored on information device 1010during system use or other condition occurs (e.g., expiration of usage,completion of system activity, etc.), information device 1010 is removedfrom system 100 to retrieve and process the collected information storedthereon. The stored information may be retrieved by a workstation orcomputer system 1004. A computer interface 1002 is coupled to computersystem 1004 and receives or interfaces information device 1010. Thecomputer interface may be disposed within or be external of the computersystem. Interface 1002 is substantially similar to system interface 1008and transfers information with information device 1010. The computersystem retrieves the collected information from the information device(e.g., card) via interface 1002 and processes the information togenerate reports. A user typically communicates by telephone (or othermanner) with the service provider to ascertain a password to enableretrieval of the stored information by the computer system. Basically,the computer system may provide a user interface to enable a user toenter a password and then retrieve the information. A printer 1018 maybe connected directly to computer system 1004 or be accessible via anetwork 1011 (e.g., LAN/WAN/Internet, etc.) to print the generatedreports. Further, the password may enable the computer system toreplenish the card (e.g., revise the usage parameters) to facilitatefurther use of a thermal treatment system. In other words, the computersystem and computer interface may reprogram information device 1010 withthe next password and other information for subsequent use.

Computer system 1004 may further be in communication with a remoteserver computer system 1009 via network 1011 (e.g., LAN/WAN/Internet,etc.). The server system is coupled to an information base 1015. In thiscase, information device 1010 is removed from system 100 and insertedinto or coupled to computer interface 1002 as described above.Information stored on the information device (e.g., card) may beretrieved by computer system 1004 as described above and transferred toremote server system 1009 via network 1011 for storage in informationbase 1015. A user may visit a specific or service provider web site viacomputer system 1004 to download information from the information deviceto the server system for generation of reports and/or storage at theservice provider or a user secure web site for later processing. Thereports may be generated via the server system or web site and printedby printer 1018 that may be coupled to computer system 1004 and/or thenetwork. Information device 1010 may be reprogrammed by computerinterface 1002 and computer system 1004 in accordance with the serversystem or web site to facilitate additional use of a thermal treatmentsystem (e.g., usage and/or control parameters may be updated) asdescribed above. The user may receive a bill for the additional usagefrom the service provider.

Once the user completes the desired actions via computer system 1004,information device 1010 is removed from interface 1002 and received bysystem 100. System interface 1008 reads the usage and/or controlparameters to control use and operation of the thermal treatment systemas described above.

Yet another embodiment of usage control unit 1001 in communication witha network is illustrated in FIG. 15. Specifically, usage control unit1001 includes display 114, a communications device 1014 and/or timer120. The communications device is in communication with a network 1011(e.g., LAN/WAN/Internet, etc.) and coupled to temperature controller102, display 114 and/or timer 120. The communications device may beimplemented by any conventional or other processing and/orcommunications devices (e.g., router, modem, processing system,microprocessor, controller, etc.) and basically performs the functionssubstantially similar to those performed by system interface 1008described above of collecting information pertaining to system activityfrom the temperature controller and/or sensors and monitoring andcontrolling system use based on control and usage parameters. Thecommunications device further transfers that information over thenetwork. The thermal treatment system operates as described above tothermally treat medical items and collect information pertaining tosystem activity and usage. Communications device 1014 may storecollected information and/or parameters in a memory 1016, where thecollected information is transmitted over network 1011 to a servercomputer system 1020 for storage in an associated information base 1030.The server system is coupled to network 1011 and basically serves as ahost system to collect information from the thermal treatment system andstore that information in information base 1030.

The server system further provides the thermal treatment system withusage and control parameters to enable the communications device tomonitor and control system use as described above. A user may access theserver system via a workstation or computer system 1004 coupled tonetwork 1011 in order to retrieve and process the collected informationto generate reports. The server system typically provides a userinterface, preferably in the form of a service provider web site, tofacilitate these user functions. The reports may be printed via aprinter 1018 coupled to network 1011 or computer system 1004. A serviceprovider may control access to the web site and/or system data based onvarious techniques (e.g., passwords, subscriptions, accounts, etc.).Thus, the thermal treatment system may monitor and control use viaserver system 1020 and information base 1030 without use of aninformation device. Alternatively, the usage control unit may furtherinclude system interface 1008 and information device 1010, each asdescribed above, where the communications device is further coupled tothe system interface and serves to transfer information between thatinterface and the network. The information device may contain variousinformation (e.g., user or system identification, usage information,etc.) and receive collected information as described above. Theinformation stored on the information device may be transferred to theserver system to enable a user to retrieve information via the web site.In addition, the control and usage parameters stored on the informationdevice may be revised (e.g., replenish usage, etc.) by the systeminterface in accordance with actions by a user on the web site. Theinformation store and information device may contain or receive anyinformation in any desired combination.

The medical item thermal treatment system may transfer information toserver system 1020 for storage within information base 1030 inreal-time, as events occur. This allows a user at workstation 1004 tomonitor the status of one or more medical item thermal treatment systemsand the status of medical items undergoing a warming/cooling cycle viadisplays or reports generated from real-time and/or historic datacontained within the information base. For example, a user within anoperating room, or remote to an operating room, can monitor one or moremedical item thermal treatment systems. Information within theinformation base can be queried using information base query techniquesor displayed via a dynamically updated user interface viewed atworkstation 1004 that presents the user with a selected view of one ormore medical item thermal treatment systems. Visible and/or audiblealarms may alert the user to conditions that exceed established controlparameters or prescribed requirements. By way of example, if a medicalitem solution exceeds a predetermined temperature, or has maintained atemperature for a period of time that exceeds a user configurablemaximum value, the user can be alerted in real-time as the conditionsoccur and take corrective action, as necessary.

Further, usage and control parameters may be updated within theinformation base by a user, via the web site, and immediately downloadedto the affected medical item thermal treatment system in real-time, orupon occurrence of a scheduled or event based trigger. For example, auser can review the use remaining on one or more medical item thermaltreatment systems 100, and authorize additional blocks of use, asnecessary. Use can be authorized using a service provider dynamic userinterface or web site displayed at workstation 1004. Payment foradditional use can be coordinated directly with the service provider, byphone, or via a conventional debit/credit based electronic transaction.

The manner in which a medical item thermal treatment system monitors andcontrols system use or activities according to the present invention isillustrated in FIG. 16. Specifically, thermal treatment system 100(FIGS. 13-15) is enabled at step 1032 and receives, at step 1034, usageand control parameters (e.g., log event definitions, timeouts, timerperiods, initial usage values, threshold values, log messages, storagedestinations, etc.) from a source (e.g., information device 1010, aserver system, etc.) as described above. The thermal treatment systemapplies the received parameters, at step 1036, to monitor and controlsystem use. Next, the medical item thermal treatment system waits, atstep 1038, for insertion of a medical item or receipt of revisedparameters. If a medical item is received, at step 1040, and the system,at step 1044, determines that usage remains available, the thermaltreatment system proceeds, at step 1050, to initiate a warming/coolingcycle based upon the operational control and/or usage parametersreceived in step 1034.

If, at step 1040, a medical item is not received and the systemdetermines, at step 1042, that revised control and/or usage parametersare received, operation returns to step 1036, where the revisedparameters are applied.

If, at step 1044, the usage parameter values have fallen below apredetermined threshold, operations can be terminated, at step 1046, oran alert can be generated for the user and logged, at step 1048, priorto proceeding with a warming/cooling cycle, at step 1050.

Once the thermal treatment system proceeds with a warming/cooling cyclefor a medical item, at step 1050, the thermal treatment system monitorsheating/cooling events, sensor values and/or system timers. Uponoccurrence of a defined event or a predetermined timeout period, at step1052, the thermal treatment system, at step 1054, generates and stores alog entry and/or updates stored values used to monitor and track usageand other system status values. Upon handling the log event, the thermaltreatment system proceeds with the warming/cooling cycle, at step 1050,and continues to monitor/log events, at steps 1052, 1054 until themedical item warming/cooling cycle is complete, at step 1056. At step1058, the medical item thermal treatment system updates usage parametervalues (e.g., remaining usage time, warming/cooling cycle counters,etc.). If a power down of the system is initiated, at step 1060,operations cease; otherwise, operations proceed to step 1038, and thesystem waits for insertion of a new medical item or revised parametersas described above.

The manner in which monitoring and control of system use is accomplishedvia a local or remote computer system according to the present inventionis illustrated, by way of example only, in FIG. 17. Specifically,workstation or computer system 1004 (FIGS. 14-15) or any other networkor locally connected device initiates, at step 1062, a user interfaceand, at step 1064, establishes a connection with medical item thermaltreatment system information base 1004, 1030 or information device 1010provided by the user as described above.

Once a connection is established, a user can choose, at step 1066, togenerate a display or report that contains information about system use.A user may select one or more medical item thermal treatment systems forwhich information is to be included in the display or report whenaccessing the information store. At step 1070, the user selects thedisplay or report to be generated. The display or report generated canbe displayed and/or printed, at step 1072, to one or more local ornetwork connected display devices and/or printers.

If one or more medical item thermal treatment systems support areal-time network interface with the medical item thermal treatmentsystem information base, a user can request real-time monitoring ofevents and/or monitored parameters. In particular, the user chooses, atstep 1074, to monitor operations in real time, and selects, at step1076, one or more medical item thermal treatment systems for whichinformation is to be included in the real-time display. Next, the userselects, at step 1078, a display format that supports the informationthe user is interested in monitoring and initiates, at step 1080, thereal-time monitoring process. As a result, the selected display ispresented and updated in real-time as relevant information changeswithin the medical item thermal treatment system information base. Thedisplay may be printed to provide reports of conditions at varioustimes.

A user can select, at step 1082, to authorize additional medical itemthermal treatment system usage. The user may select one or more medicalitem thermal treatment system(s) to which usage is to be added whenaccessing the information base. At step 1086, the user selects theusage-policy/usage-amount to be added to the medical item thermaltreatment system based upon the information displayed, and a paymentmethod, such as a debit or credit account. The user finalizes the usagetransaction, at step 1088, upon which authorized use parameters in theinformation base or stored on information device 1010 are updated.

A user can select, at step 1090, to change one or more controlparameters. The user may select one or more medical item thermaltreatment systems to which control parameters are to be updated whenaccessing information store 1030. At step 1094, the user selects andupdates the associated user controlled parameters. The user finalizes,at step 1096, the change control parameters transaction, therebyupdating control parameters in the information base and/or informationdevice. The control parameters can be used to define log events, logevent messages, log event heartbeat timers, control point decisions,etc., depending upon the monitoring and control capabilities supportedby the respective medical item thermal treatment systems as describedabove.

Thermal treatment system 100 (e.g., monitoring conditions, transmittingand/or printing information, etc.) may be in the form various thermaltreatment systems for heating/cooling and/or delivering fluids (e.g.,open basin warmer/cooler, IV bag or bottle warmer/cooler, irrigation bagor bottle warmer/cooler, IV fluid line warmer/cooler, irrigation fluidline warmer/cooler, a hand piece delivery warmer/cooler, an instrumentand/or disposable fluid heating/cooling system (e.g., Hotline, Ranger orCincinnati Sub Zero systems, etc.), etc.). By way of example only, amedical item warming/cooling system 400 with monitoring, transmission,printout and/or usage control capabilities is illustrated in FIGS.18-19. The system is of the type disclosed in U.S. Pat. No. 6,660,974(Faries, Jr. et al.). Specifically, medical item warming/cooling system400 includes a housing 402, an access door 404 with a handle 406, acompartment 407 and a control panel area 408. The system may stackvertically upon other medical item systems using detents 410 in the topof housing 402 and protrusions 412, protruding from the bottom ofhousing 402 to align vertically stacked system units.

Control panel area 408 typically includes a power switch 414 and adisplay 416 with control buttons 418 used by a user to enter selectionsinto the system. System operation is typically controlled by atemperature controller in accordance with a set point temperatureentered by a user and temperatures measured by a temperature sensor asdescribed above. The system typically employs heated air to heat medicalitems placed within compartment 407.

Solution bags (e.g., conventional solution bags or the solution bagsdescribed above) or other medical items are disposed within a drawer 434(FIG. 19) for insertion into compartment 407. Drawer 434 includes aseries of receptacles 480 each for receiving a corresponding medicalitem. The receptacles may include a series of monitoring assemblies 420to monitor the temperature and residence time (e.g., amount of time anitem resides within the warmer unit) of individual medical items heatedwithin the warmer unit. Specifically, monitoring assemblies 420 are eachmounted below the approximate center of a receptacle floor portion of acorresponding receptacle 480, where the monitoring assemblies may bemounted to the drawer via any suitable mounting devices (e.g., clamps,brackets, adhesives, etc.). The monitoring assemblies each include anitem sensor or switch 422 to detect when a medical item is placed withina corresponding receptacle 480 and a temperature or other sensor 424 todirectly measure the temperature or other conditions of the medical itemwithin that receptacle.

The system includes a configuration similar to that described above forsystem 100 and may further include report unit 101 and/or usage controlunit 1001 to generate, transmit and/or print reports and/or controlsystem usage as described above for system 100. An interface 20 may bedisposed in a receptacle in the form of a wireless transmitter/receiver(e.g., RF, infrared, etc.), bar code scanner or connector or port tocommunicate with the medical item and/or identify the medical item tothe system for storage of monitored information as described above.

Another exemplary thermal treatment system 500 with monitoring,transmission printout and/or usage control capabilities is illustratedin FIG. 20. The system is of the type disclosed in U.S. Pat. No.6,371,121 (Faries, Jr. et al.). Specifically, system 500 includes acabinet or system housing with a top surface 502 supporting a basin 504.System 500 is designed to be covered with a sterile drape 512 thatenvelopes the cabinet and basin surfaces, thereby creating a sterilefield for warming and/or cooling sterile fluids. System 500 is furtherequipped with a power on/off button 506, an optional display 508 withinput/output control buttons 510 and a temperature controller to controlsystem operation in accordance with a set point temperature entered by auser and a temperature measured by a temperature sensor as describedabove. The system includes a configuration similar to that describedabove for system 100 and may further include report unit 101 and/orusage control unit 1001 to generate, transmit and/or print reportsand/or control system usage as described above for system 100.

Yet another exemplary warming/cooling system 600 for IV lines withmonitoring, transmission, printout and/or usage control capabilities isillustrated in FIG. 21. The system is of the type disclosed in U.S.Patent Application Publication No. 2003/0114795 (Faries, Jr. et al.).Specifically, medical item warming/cooling system 600 includes a systembase 602 that houses a heating element and corresponding temperaturesensor (not shown). The base top surface receives a cassette of IVtubing 606. The cassette may include any of the devices or indicia(e.g., monitoring device, memory device, bar code, transponder, inkcells, etc.) described above for solution bag 2 to monitor compliancewith prescribed requirements for the IV solution. Lid or cover 608includes an additional heating element and closes upon the cassetteloaded within system base 602, thereby substantially encasing steriletubing 606. A first end 610 of sterile tubing 606 with connector 612 anda second end 614 of sterile tubing 606 with connector 616 protrude frommedical item warming/cooling system 600 to connect to an IV line. Acontroller 618 includes a display and control input/output buttons tocontrol operation of medical item warming/cooling system 600 inaccordance with a set point temperature entered by a user and atemperature measured by the temperature sensor as described above. Thesystem includes a configuration similar to that described above forsystem 100 and may further include report unit 101 and/or usage controlunit 1001 to generate, transmit and/or print reports and/or controlsystem usage as described above for system 100.

A further temperature control system of the present invention forthermally treating and/or monitoring medical solution containers (e.g.,bags or bottles containing saline or intravenous (IV) solutions,antibiotics or other drugs, blood, etc.) or other medical items (e.g.,instruments, blankets, etc.) with direct measurement of medical itemtemperature and display of medical item residence time within the systemis illustrated in FIGS. 22-24. Specifically, temperature control system700 includes a cabinet or system housing 704 with substantially similardrawers 706 a, 706 b for enabling placement and removal of medicalitems, such as intravenous solution bags, within the system and acontroller 722 for controlling heating of the drawers to maintain thebags at the same or different desired temperatures. Cabinet 704 isgenerally in the form of a rectangular box and includes top and bottomwalls 710, 712, side walls 714, 716 and front and rear walls 718, 720.The cabinet walls are each substantially rectangular and collectivelydefine a cabinet interior. Further, side wall 716 typically includes aseries of labels 724, such as fuse warning labels and labels providingother information, and a plurality of fuse holders 726 for receivingfuses of the system control circuitry described below. The cabinet istypically constructed of electro-galvanized steel (e.g., eighteen gauge)or other suitably sturdy material, and may be of any size or shape.

Drawers 706 a, 706 b are generally disposed in vertical alignment infront wall 718 toward side wall 714, while controller 722 is disposed infront wall 718 adjacent drawer 706 a and power switch 723 toward sidewall 716. Controller 722 enables entry of a desired or set pointtemperature associated with each drawer and controls heating ofintravenous solution bags residing within the drawers based on theassociated desired temperatures as described below. Power switch 723 isgenerally disposed below controller 722 and enables power to thecontroller for heating intravenous solution bags disposed within thedrawers. By way of example only, cabinet 704 includes two drawers,however, any quantity (e.g., at least one) of drawers, power switches,controllers and control circuitry may be utilized, while the cabinetcomponents may be arranged in any fashion.

Drawers 706 a, 706 b each include a front wall or door 728, a rear wall730, a bottom wall 732 and side walls 734, 736. The drawer walls areeach substantially rectangular and collectively define a compartment ordrawer interior having an open top portion for enabling placement andremoval of intravenous solution bags within the drawers. The drawers maybe of any size or shape, and the system may include any combination ofdrawers of different or substantially similar types.

Door 728 includes a handle 738 typically disposed toward the door upperportion, whereby the handle may be implemented by any conventional orother type of handle. Alternatively, the handle may be disposed on thedoor at any suitable location. Door 728 generally enables acorresponding drawer to pivot into and out of the cabinet as describedbelow, and is typically constructed of electro-galvanized steel (e.g.,sixteen gauge) or other suitably sturdy material. The door furtherincludes a substantially rectangular opening 740 covered by asubstantially transparent material 742, such as glass or plexiglass, toserve as a window to enable viewing of the intravenous solution bags andmaintain heat within the cabinet. The door, opening and transparentmaterial may be of any size or shape. Divider walls 744, 746 aredisposed within each drawer interior to partition that interior intosub-compartments or bins 752 a, 752 b, 752 c. In particular, dividerwalls 744, 746 (FIG. 24) extend from rear wall 730 substantially inparallel to, and include dimensions substantially the same as, sidewalls 734, 736. The front and rear edges of dividers 744, 746 are bentat an angle of approximately ninety degrees relative to the respectivedivider wall body portions, and extend transversely toward side wall 734to form ledges 748, 750, respectively. Similarly, the front edges ofside walls 734, 736 are bent at an angle of approximately ninety degreesrelative to the respective side wall body portions, and extendtransversely toward each other to form ledges 749, 751, respectively.Further, the front edge of bottom wall 732 is bent at an angle ofapproximately ninety degrees relative to the bottom wall body portion,and extends upward toward a drawer upper portion to form ledge 753.Ledges 750 enable the divider walls to interface rear wall 730, whileledges 748 include a recess or gap to permit the divider walls to engageand secure transparent material 742 within opening 740 of door 728.Moreover, ledges 748, 749, 751 and 753 enable the door to interface thedrawer side, bottom and divider walls. Each drawer sub-compartment istypically configured to accommodate a single intravenous solution bag,and is defined by the drawer rear, bottom, side and divider walls.Specifically, sub-compartment 752 a is defined between side wall 734 anddivider wall 744, sub-compartment 752 b is defined between divider walls744, 746 and sub-compartment 752 c is defined between divider wall 746and side wall 736. The drawer side, rear, bottom and divider walls aretypically constructed of copper or other suitable heat conductingmaterial to conduct and evenly distribute heat to the intravenoussolution bags disposed within the drawer as described below.

A heating element or pad 754 is typically disposed on the underside ofeach drawer bottom wall 732, whereby the heat applied by the heating padis conducted by the drawer bottom, side, rear and divider walls toprovide an even heat distribution to the intravenous solution bagsresiding in the sub-compartments of that drawer. In other words, eachindividual drawer sub-compartment includes bottom, side and rear wallsthat conduct and directly transmit heat from the heating pad to theintravenous solution bag contained in that sub-compartment, therebypreventing other intravenous solution bags residing in the cabinet frombeing affected by the applied heat. The application of heat from thesub-compartment walls provides a relatively uniform heat distributionand prevents the occurrence of certain intravenous solution bags (e.g.,bags disposed near the heat source) attaining higher temperatures thanthe remaining bags (e.g., bags disposed at other locations within thecabinet) as is typically present in common single heat source systems.Alternatively, the heating pad may be disposed on the side or rear wallsof each drawer. The heating pad is preferably configured to cover only aportion of a drawer bottom wall, but may include any type ofconfiguration (e.g., strips, bars, segments, include various openings,etc.). A temperature sensor 756 is typically disposed on the undersideof each drawer bottom wall 732 generally within the confines of thecorresponding heating pad (e.g., the portion of the heating pad notcovering the drawer bottom wall). The temperature sensor is preferablyimplemented by a conventional RTD temperature sensor and measures thetemperature of the bottom wall of the corresponding drawer. However, thetemperature sensor may be implemented by any conventional or other typeof temperature sensor, and may be disposed at any suitable location onor within a drawer. The drawer may further include any type of sensorsor sensing devices (e.g., temperature sensors, presence sensors, weightsensors, volume sensors, pressure sensors, flow sensors, fluid sensors,fluid level sensors, etc.) to measure and provide any desiredinformation. The temperature measurement of sensor 756 is provided tothe controller for control of the corresponding heating pad as describedbelow.

An exemplary heating pad of the type employed by temperature controlsystem 700 is illustrated in FIG. 25. Specifically, heating pad 754 issubstantially rectangular and includes a substantially rectangularopening 758. A connector 760 is disposed along a heating pad shorterdimension edge to facilitate connections for the heating pad. Theheating pad is preferably implemented by a conventional etched foilsilicon rubber heater (e.g., forty-four watts, one-hundred twenty VAC)having an extra layer of silicon rubber on the adhesive side. Theheating pad further includes a pressure sensitive adhesive forattachment to a drawer bottom wall. Temperature sensor 756 is typicallydisposed within opening 758 to measure the temperature of acorresponding drawer bottom wall as described above. The heating pad maybe of any quantity (e.g., at least one), shape, or size, and may includeany configuration that covers the entirety or a portion of acorresponding drawer bottom wall. In addition, the heating element orpad may be implemented by any conventional or other type of heater orheating element (e.g., heating coils) to heat the drawers.

Referring back to FIGS. 22-24, side walls 734, 736 of drawers 706 a, 706b interface respective doors 728 via posts 762 to secure the drawers tothe doors. Each door 728 further includes a pivoting mechanism having apivot hinge (not shown) and a locking hinge 764 to enable acorresponding drawer to angle forward and pivot outward from the cabinetinterior into an open position. In particular, locking hinge 764includes a receptacle 766 disposed on a corresponding door 728, a curvedtrack or slide 768 and a pin or bolt disposed within the cabinetinterior (not shown). Receptacle 766 is disposed toward an intermediateportion of the corresponding door and extends from that door interiorsurface toward the cabinet interior. The receptacle includes an openingthrough which a pin or bolt 770 is inserted to connect a proximal end ofslide 768 to the corresponding door.

Curved slide 768 typically extends from receptacle 766 of thecorresponding door into the cabinet interior and curves toward cabinetbottom wall 712. The slide includes an opening 772 extending along theslide from the receptacle into the cabinet interior, whereby anassociated cabinet interior bolt is disposed within and through theopening to enable the corresponding drawer to pivot out of and into thecabinet interior to open and closed positions, respectively. The distalend of the slide, in combination with the associated cabinet interiorbolt, serves as a stop to limit pivoting or the forward angle of thecorresponding drawer. Locking hinge 764 may be disposed adjacent eitherside wall 734, 736 of the corresponding drawer, or a door may includedual pivoting mechanisms, whereby a mechanism is disposed adjacent eachcorresponding drawer side wall. An operator typically grasps handle 738of a corresponding door and applies force to draw that handle forward,thereby forcing slide 768 of that door forward, while the associatedcabinet interior bolt traverses corresponding slide opening 772. Whensufficient force is applied to the handle, the distal end of thecorresponding slide opening is caused to engage the associated cabinetinterior bolt to prevent further pivoting of a corresponding drawer.Conversely, force may be applied to the handle to facilitate pivoting ofthe corresponding drawer toward the cabinet to a closed position,whereby the corresponding slide is forced into the cabinet interior,while the associated cabinet interior bolt traverses corresponding slideopening 772.

The system may further include temperature sensing devices 125 (FIG.23), preferably in the form of temperature sensing strips, and timingdevices or timers 702 to measure and display the residence time of amedical item within an associated sub-compartment. Temperature sensingdevices 125 are disposed within respective sub-compartments 752 a, 752 band 752 c of each drawer proximate window or material 742. The medicalitems within the sub-compartments are in thermal relation with thecorresponding temperature sensing devices to enable the devices tomeasure and display the item temperatures as described below. Material742 is substantially transparent to enable viewing of the temperatureindications through the window.

Temperature sensing devices 125 are each preferably in the form of asubstantially rectangular strip and include a temperature scale 122arranged in a vertical fashion to measure and display a solutiontemperature in a particular temperature range. The temperature scaletypically includes numerical indicators 130 arranged in sequentialorder, whereby each indicator represents a ten degree temperatureinterval (e.g., 70° F., 80° F., 90° F., 100° F., 110° F. as viewed inFIG. 23).

The temperature sensing strip preferably includes a series oftemperature sensitive substances that provides visual color changes toor illuminates the temperature scale indicators to display a solutiontemperature. In particular, each temperature scale indicator 130 istypically associated with a temperature sensitive substance having aparticular temperature threshold range corresponding to that indicator.When the solution temperature is within the threshold temperature rangeof a substance, that substance changes color or illuminates theassociated temperature scale indicator to display the solutiontemperature. For example, if the solution has a temperature of 90° F.,then only the temperature scale indicator representing a ninety degreetemperature changes color or becomes illuminated to visually display thesolution temperature. The temperature thresholds may be adjusted in anymanner to enable a single or a plurality of temperature scale indicatorsto be illuminated in response to a solution temperature residing betweensuccessive temperature scale indicators. Further, the temperaturethresholds may be set to illuminate a successive indicator (e.g., a 90°F. indicator may be set to illuminate at any temperature between 90°F.-100° F.).

The temperature sensing strip is preferably implemented by aconventional temperature strip having common temperature sensitivesubstances (e.g., a liquid crystal composition), such as the types ofsubstances disclosed in U.S. Pat. No. 3,651,695 (Brown), U.S. Pat. No.3,861,213 (Parker), U.S. Pat. No. 3,864,976 (Parker), U.S. Pat. No.4,859,360 (Suzuki et al) and U.S. Pat. No. 5,806,528 (Magliochetti). Thedisclosures of the foregoing patents are incorporated herein byreference in their entireties. By way of example only, each temperaturesensing device 125 includes a configuration where temperature scale 122has duplicate temperature scale indicators 130 for each temperaturelevel with corresponding temperature sensitive substances disposedbetween the duplicate scale indicators and displays temperatures in therange of 70° F.-110° F., whereby the duplicate temperature scaleindicators 130 for each level represent a successive ten degreetemperature interval (e.g., 70° F., 80° F., 90° F., 100° F. and 110° F).However, the temperature sensing device may be of any size or shape,while the temperature scale may include any quantity or types ofindicators for representing any sized intervals in any desiredtemperature range.

Timers 702 are each associated with a corresponding drawersub-compartment and are disposed on front wall 718 adjacent thecorresponding drawer. Timers 702 each include a display 140 to indicatethe amount of time a medical item has resided within a correspondingsub-compartment. In other words, the timer measures and indicates theamount of time a medical item has been warmed by the system. The timermay be implemented by any conventional or other timing or time measuringdevices and may include any conventional or other type of display (e.g.,LED, LCD, etc.).

Timers 702 are each controlled by a corresponding timer switch 150 (FIG.22) to measure and indicate residence time in accordance with placementof a medical item within that sub-compartment. Timer switch 150 isdisposed within each sub-compartment on drawer back wall 730. Basically,when a medical item is placed into a sub-compartment and against a timerswitch, the timer switch enters a closed state and enables acorresponding timer 702 to begin measuring elapsed time. The elapsedtime is displayed on display 140 of that timer, preferably in the formatof hours, minutes and seconds. However, the elapsed time may be measuredand/or displayed in any desired format or fashion (e.g., days, hours,minutes, seconds, etc.). When the medical item is removed from thesub-compartment, the timer switch enters an open state, thereby causingthe timer to reset as described below. The timer display notifiesmedical personnel of the residence time of a medical item within thesub-compartment. In other words, the timer informs medical personnel ofthe amount of time a medical item has been warmed. Since medical itemstypically have limits with respect to warming time, medical personnelmay remove the warmed medical item prior to excessive heating of themedical item and reduction in effectiveness.

Controller 722 typically includes a display 774 (e.g., LED or LCD) and aplurality of input devices or buttons 776 for enabling entry of adesired or set point temperature for each drawer. Input devices 776 aremanipulated to enable entry of the desired temperatures, while display774 may alternatively indicate the actual temperature for each drawermeasured by a corresponding temperature sensor 756 (FIG. 24) or thedesired or set point temperature for each drawer entered by theoperator. Display 774 typically displays the measured drawertemperatures, and may be directed, via the input devices, to display theset point temperatures.

The controller essentially implements a feedback control loop to controlheating of the drawers. Specifically, controller 722 receives atemperature signal from each temperature sensor 756 indicating thetemperature of the corresponding drawer bottom wall. In response to themeasured temperature of a corresponding drawer bottom wall being equalto or exceeding the desired temperature associated with that drawer, thecontroller disables power to the associated heating element via a solidstate relay described below. Conversely, when the measured temperatureof the corresponding drawer bottom wall is below the desired temperatureassociated with that drawer, the controller enables power to theassociated heating element via the solid state relay. The controller maybe implemented by any conventional or other controller, processor orcircuitry utilizing any control algorithm (e.g., fuzzy logic, PID, etc.)to control the heating elements.

An exemplary control circuit of the temperature control system isillustrated in FIG. 26. Specifically, system control circuit 777includes control circuits 778 a, 778 b to control heating ofcorresponding drawers 706 a, 706 b, respectively. The control circuitsare coupled to controller 722 and power switch 723 to enable power tothe circuits and control the heaters. A conductor 780 typically suppliesa positive potential, while a conductor 782 provides a negative orreference potential. A conductor 196 is connected to ground. A fuse 786is connected in series with conductor 780 and the power switch, while afuse 790 is connected between the controller, power switch and solidstate relays 788 of control circuits 778 a, 778 b to prevent surges fromdamaging the circuitry. Power switch 723 is connected to conductors 780,782. The power switch is further connected to controller 722 and heaters754 and solid state relays 788 of control circuits 778 a, 778 b toenable power to those components.

Control circuit 778 a includes temperature sensor 756, conventionalsolid state relay 788, a conventional temperature cut out switch 792 andheating element or pad 754. Controller 722 receives power from powerswitch 723 and is further connected to temperature sensor 756 and solidstate relay 788 of control circuit 778 a. The temperature sensormeasures a corresponding drawer bottom wall temperature and transmits asignal to controller 722 indicating that temperature. The controllercontrols the solid state relay to enable or disable power to the heatingpad based on the measured temperature as described above. The solidstate relay is connected to the heating pad, while temperature cut-outswitch 792 is connected between the relay and heating pad to disable theheating pad in response to detecting a heating pad temperature in excessof a predetermined threshold.

Control circuit 778 a further includes timers 702, reset relays 170,timer switches 150, a connection terminal 190 and a power source 160.The power source is connected to the solid state relay and connectionterminal, while the timer switches 150 are each connected between theconnection terminal and a corresponding reset relay 170 to facilitatecontrol of the corresponding sub-compartment timer in accordance withthe presence of a medical solution container within thatsub-compartment. Each reset relay is connected to a corresponding timerand timer switch and may be implemented by any conventional or otherrelay type device. Basically, the timer switch enables a correspondingreset relay to control a corresponding timer. When a medical solutioncontainer is present in a sub-compartment, the timer switch is in aclosed state as described above. Accordingly, the connection, via theconnection terminal, between the power source and reset relay isenabled. The reset relay controls the reset of a corresponding timer702. The timer basically resets when the reset line is low or grounded.Thus, when a medical item is removed from a sub-compartment and thecorresponding timer switch enters an open state, the corresponding resetrelay does not receive power from the power source and provides a lowsignal to the timer reset line, thereby facilitating a timer reset. Whenthe timer switch enters a closed state due to the presence of a medicalsolution container in the sub-compartment, the corresponding reset relayreceives power signals from the power source, thereby providing a highsignal to the timer reset line enabling the timer to operate. Controlcircuit 778 a may be implemented by any conventional circuitrycomponents performing the above-described functions. Control circuit 778b is connected in parallel with and is substantially similar to controlcircuit 778 a described above to control heating of drawer 706 b.

System 700 includes a configuration similar to that described above forsystem 100 and may include report unit 101 and/or usage control unit1001 coupled to controller 722 to generate, transmit and/or printreports and/or control system usage as described above for system 100.The drawer sub-compartments may each further include an interface 20 inthe form of a wireless transmitter/receiver (e.g., RF, infrared, etc.),bar code scanner or connector or port to communicate with the medicalitem or identify the medical item to system 700 for storage of monitoredinformation as described above.

Operation of the temperature control system is described with referenceto FIGS. 22-26. Initially, an operator selects intravenous solution bags(e.g., containing intravenous solution) or other medical items forheating within the cabinet and determines appropriate temperatures forthe items. The items may include the devices described above forsolution bag 2. The operator subsequently selects a drawer 706 a, 706 band enables power switch 723, whereby the operator grasps and appliesforce to handle 738 of the selected drawer to pivot that drawer outwardfrom the cabinet interior to an open position. Intravenous solution bagsare disposed within any quantity (e.g., at least one) or combination ofcorresponding drawer sub-compartments 752 a, 752 b, 752 c such that anyone sub-compartment contains a single intravenous solution bag. Inresponse to placement of a container in the sub-compartment, thecontainer engages and causes closure of a corresponding timer switch150. The switch closure provides a connection between power source 160and corresponding reset relay 170 that initiates the timer. The selecteddrawer is subsequently pivoted into the cabinet interior to a closedposition, while the timer continuously displays the elapsed time tomedical personnel on timer display 140 as described above. The desiredtemperature for each utilized drawer is entered into controller 722 viainput devices or buttons 776. The controller receives signals fromcorresponding temperature sensors 756 (FIG. 24) and determinesappropriate controls for solid state relays 788 (FIG. 26) to enable ordisable power to heating pads 754 of the utilized drawers as describedabove. The heating pads apply heat to corresponding drawer bottom walls,whereby the drawer rear, side and divider walls conduct heat from thebottom wall to evenly distribute heat to the intravenous solution bagsresiding within the corresponding drawer sub-compartments as describedabove.

Controller 722 displays on display 774 each drawer bottom walltemperature measured by a corresponding temperature sensor 756, and maybe directed to alternatively display the desired temperature entered foreach drawer based on manipulation of input devices 776. Temperaturesensing devices 125 measure and display the medical item temperatureduring heating as described above. Further, the intravenous solutionbags may be viewed through transparent material 742 during heating.Moreover, system 700 may collect and provide information or reports(e.g., FIGS. 12A-12I) and/or control system usage as described above forsystem 100, where the reports or information can be transmitted to aninternal printer 110, display 774 or to a local or remote externaldevice (e.g., printer, display, database, medical item, etc.) asdescribed above.

When the intravenous solution bags have attained the desiredtemperature, the selected drawer is pivoted to an open position asdescribed above, whereby the heated bags are removed fromsub-compartments of the selected drawer for use. The corresponding timerswitches subsequently enter an open state, thereby resetting thecorresponding timers and displays. Additional intravenous solution bagsmay replace the removed heated bags within those sub-compartments forheating by the system. It is to be understood that either or both of thedrawers may be used and independently controlled in substantially thesame manner described above to maintain items at the same or differentdesired temperatures. Further, any quantity of intravenous solution bagsor items may be disposed within the sub-compartments and drawers forheating by the cabinet.

Yet another temperature control system of the present invention forthermally treating and/or monitoring medical solution containers (e.g.,bags or bottles containing saline or intravenous (IV) solutions,antibiotics or other drugs, blood, etc.) or other medical items (e.g.,instruments, blankets, etc.) with direct measurement of medical itemtemperature and display of medical item residence time within the systemis illustrated in FIGS. 27A-27C. Initially, the system is of the typedisclosed in aforementioned U.S. patent application Ser. No. 10/076,112.Specifically, system 800 includes a housing 802 including a heatingcompartment 804 and a storage compartment 806 disposed above the heatingcompartment. The heating compartment includes a front wall 810, a rearwall 812, side walls 814, 816, a bottom wall 820 and a front panel 840that collectively define the heating compartment interior. A door 830 isdisposed on the housing to cover a heating compartment open portion thatfacilitates placement and removal of items within the heatingcompartment as described below. Front and rear walls 810, 812 aresubstantially rectangular and are attached to and extend between sidewalls 814, 816. Front wall 810 has a height substantially less than thatof rear wall 812. Bottom wall 820 is substantially rectangular and isattached to the bottom edges of the heating compartment front, rear andside walls. Side walls 814, 816 are generally rectangular withrespective truncated upper front corner sections. The truncated sectionof side wall 814 includes an angled edge that extends from front wall810 toward the storage compartment. The truncated section of side wall816 includes a similarly angled edge.

Front panel 840 includes a control panel 841 and a projection 853. Thecontrol panel is substantially rectangular and is attached to front wall810 and the angled edge of side wall 814. The control panel has atransverse dimension substantially less than the distance between sidewalls 814, 816 and is oriented at an angle toward rear wall 812 similarto that of the angled edge of side wall 814. Projection 853 issubstantially rectangular and is attached to front wall 810, a controlpanel lower section and side wall 816. The projection extends from thefront wall toward the storage compartment for a slight distance and isoriented at an angle similar to that of control panel 841. The open areabetween control panel 841, side wall 816 and projection 853 defines theheating compartment open portion.

Storage compartment 806 is disposed above heating compartment 804 andincludes a top wall 818, side walls 824, 826 and front and rear walls828, 832 that collectively define the storage compartment interior.Front and rear walls 828, 832 are substantially rectangular and areattached to and extend between side walls 824, 826. Front wall 828extends from the upper edges of door 830 and control panel 841, whilerear wall 832 extends from and is integral with heating compartment rearwall 812. Side walls 824, 826 are substantially rectangular and areattached to and extend between respective side edges of front and rearwalls 828, 832. The side walls respectively extend from and are integralwith respective heating compartment side walls 814, 816.

Top wall 818 is substantially rectangular and is attached to the upperedges of the storage compartment front, rear and side walls. Top wall818 further provides access to the storage compartment and is typicallypivotally connected to rear wall 832. The top wall opens upward from thestorage compartment to enable placement and removal of medical solutioncontainers within the system. Door 830 is typically pivotally connectedto the lower portion of front wall 828 and opens upward from the heatingcompartment in order to provide access to the heating compartment forplacement and removal of medical solution containers within thatcompartment. Top wall 818 and door 830 may both be partially orcompletely transparent to allow viewing of the storage and heatingcompartment interiors, respectively. In addition, top wall 818 and/ordoor 830 may include any type of handle or latching mechanism tofacilitate access to the system interior. The storage compartmentbasically houses additional medical solution containers to enable thesystem to accommodate and heat plural containers as described below.

Control panel 841 includes a power switch 843 and a controller 845 toindicate solution temperature and control operation of the system asdescribed below. Controller 845 includes a display 847 (e.g., LED orLCD) and a plurality of input devices or buttons 849. The input devicesare manipulable by a user to enable entry of a desired or set pointtemperature for a medical solution container placed within the housingcompartment. Display 847 typically displays the measured temperature ofthe solution and may further be directed, via input devices 849, todisplay the desired or set point temperature. The controller receives adesired temperature from a user and controls heating of a medicalsolution to attain that temperature as described below. The heatingcompartment houses a heating assembly 835 to uniformly apply heat to amedical solution. The heating assembly includes heating plate 850,heater 858 (FIG. 29), temperature sensor 872 and limit switch 865. Theheating plate includes bottom wall 852 and side walls 854 extending atan angle from the bottom wall longer dimensioned side edges toward theinterior surfaces of the heating compartment front and rear walls toform a generally ‘U’-shaped heating plate configuration. Heater 858 isdisposed on the bottom surface of the heating plate bottom wall. Thisarrangement facilitates rapid heating of a medical item which isespecially advantageous during employment of the system in time criticalsituations, such as in an operating room. For example, the system mayheat items to a desired temperature in the approximate range of 80° F.to 150° F. within a short time interval, generally within one hour(e.g., the particular time interval depends on various factors, such asinitial item temperature, room temperature, selected desiredtemperature, etc.).

Limit switch 865 controls heater 858 in response to placement andremoval of medical solution containers on the heating plate.Specifically, the limit switch is typically implemented in the form of apressure type switch that enables or disables the heater in response todetection of pressure (e.g., the weight of a container) applied to aportion of the heating plate. However, the limit switch mayalternatively be configured in any manner suitable for operation of thesystem. The limit switch includes a housing 862 (FIG. 27C) and an arm875 (FIG. 27B). The limit switch housing is disposed beneath the heatingplate bottom wall and includes a post or support member 874 extendingfrom the housing top surface toward the heating plate. Arm 875 isattached in a cantilevered manner to the support member. Temperaturesensors 872, 886 are mounted on arm 875 toward the arm distal end withwiring 871, 873 extending from the respective sensors to controller 845.Temperature sensor 886 basically measures excessive temperatures andserves as a cut-off switch as described below. The arm extends from thesupport member along the underside of the heating plate bottom wall toalign sensor 872 with an opening (not shown) defined in the heatingplate bottom wall. The bottom wall opening provides temperature sensor872 with access to a medical solution container placed on the heatingplate. The limit switch arm is constructed of a resilient material thatbiases the arm toward the heating plate and enables the arm to movebetween that plate and the limit switch housing. The arm bias furtherforces the temperature sensor against a medical solution containerplaced on the heating plate, thereby facilitating an accuratetemperature measurement. A contact member 876 is disposed on the limitswitch housing coincident a distal portion of the limit switch arm andextends into the limit switch housing via an opening (not shown) definedin that housing. The contact member is typically directly attached to orresiliently biased toward the limit switch arm to enable movement of thecontact member into or out of the limit switch housing in response toflexing of the limit switch arm.

The contact member is configured to actuate switch circuitry 877disposed within the limit switch housing. In particular, the limitswitch arm flexes toward the limit switch housing in response topressure applied to the arm from a medical solution container placed onthe heating plate. The contact member is subsequently urged into thehousing and interfaces the switch circuitry. This motion results inactuation of the switch circuitry and effectively closes switch 865,thereby enabling heater 858. When a container is removed from theheating plate, arm 875 is biased toward the heating plate bottom wallwith the contact member being withdrawn from the switch circuitry. Thismotion effectively results in disablement of the switch circuitry andeffectively opens switch 865, thereby disabling the heater. The limitswitch arm may further include a cut-out switch and/or additionaltemperature sensor 886 to facilitate disablement of the heater inresponse to excessive temperatures.

System 800 further includes a timer 860 (FIG. 27A) to measure anddisplay residence time of a medical item on heating plate 850. Timer 860is disposed on front wall 828 toward an upper front wall corner adjacentside wall 824. Timer 860 includes a display 862 to indicate the amountof time a medical item has resided on the heating plate. In other words,the timer measures and indicates the amount of time a medical item hasbeen warmed by the system. The timer may be implemented by anyconventional or other timing or time measuring devices and may includeany conventional or other type of display (e.g., LED, LCD, etc.). Inaddition, front wall 828 may further include a substantially rectangularwindow 864 disposed adjacent timer 860 to enable medical personnel toview and ascertain the quantity of medical items within storagecompartment 806. The window may be of any shape or size, may be disposedat any suitable locations and may be constructed of any suitablytransparent materials (e.g., glass, plastics, etc.).

System 800 may be mounted on a stand 890 to facilitate transport of thesystem to various sites (e.g., operating room, patient room, etc.). Thestand includes a post 892 and a base 893. The base is basicallyconfigured in a star type configuration and includes a hub 895 and aplurality of legs 894. The hub is generally cylindrical with legs 894extending transversely therefrom. The legs are in the form of generallyrectangular rods and each leg includes a caster or roller 896 to enabletransport of the system. Post 892 is substantially cylindrical andextends upward from hub 895. The post engages bottom wall 820 of system800 to connect the system to the stand. The post and/or system bottomwall may include any conventional or other fasteners to couple thesystem to the stand. Alternatively, system 800 may be mounted to anysupport structures (e.g., wall, pole, door, stands, etc.) via anyconventional fastening mechanisms (e.g., brackets, hooks, etc.). Thestand may be utilized with any of the thermal treatment systemsdescribed herein.

Timer 860 is controlled by limit switch 865 to measure and indicateresidence time in accordance with placement of a medical item on heatingplate 850. Basically, when a medical item (FIG. 27C) is urged bygravitational forces or manually manipulated onto the heating plate andlimit switch as described above, the limit switch enters a closed stateand enables timer 865 to begin measuring elapsed time. The elapsed timeis displayed on timer display 862, preferably in the format of hours,minutes and seconds. However, the elapsed time may be measured and/ordisplayed in any desired format or fashion (e.g., days, hours, minutes,seconds, etc.). The limit switch further actuates a time delay relaythat delays operation of the heater for a predetermined time interval.This delay enables the temperature of temperature sensor 872 to approachthe medical item temperature to provide enhanced temperaturemeasurements as described below. When the medical item is removed fromthe heating plate, the limit switch enters an open state, therebycausing the timer to reset via a reset relay as described below. Thetimer display notifies medical personnel of the residence time of amedical item on the heating plate. In other words, the timer informsmedical personnel of the amount of time a medical item has been warmed.Since medical items typically have limits with respect to warming time,medical personnel may remove the warmed medical item prior to excessiveheating of the medical item and reduction in effectiveness. Upon removalof a medical item from the heating plate, the next medical item withinthe storage compartment is gravitationally urged or manually manipulatedonto the heating plate and the limit switch enters a closed state tostart the timer and time delay as described above.

The configuration of heating plate 850 enables uniformed heating of themedical item as described above. However, the uniform heating may beadversely affected when a medical item is disoriented or improperlypositioned on the heating plate. Accordingly, system 800 may furtherinclude guides 870, 880 (FIG. 27A) to orient and ensure proper placementof a medical item on the heating plate. In particular, guide 870 istypically inserted within the system, via top wall 818, and disposedadjacent side walls 814 and 824. Similarly, guide 880 is disposed in thesystem via the top wall and disposed toward side walls 816 and 826. Theguides distal ends each rest at respective opposing ends of heatingplate 850 and extend from the heating plate through heating and storagecompartments 804, 806 to top wall 818. The guides basically form achannel therebetween having dimensions slightly larger than thecorresponding medical item. The medical item is inserted within thestorage compartment in the channel, where the medical item orientationis maintained by the guides for proper placement on the heating plate.

Referring to FIGS. 28A-28D, each guide is generally ‘L’-shaped andincludes a leg 882 and a foot 884. The leg is generally rectangular andhas a height substantially similar to the distance between the heatingplate and top wall 818. The depth of the leg is slightly less than thedistance between the storage compartment front and rear walls to enableinsertion of the guide into the system. Foot 884 is generallyrectangular and connected at an obtuse angle to a distal end of leg 882.The foot has a truncated corner on its bottom edge to provide aconfiguration to accommodate the contour of the heating plate. Theguides are preferably constructed of foam material, but may beconstructed of any suitable materials.

The dimensions of the guides may vary in accordance with the dimensionsof the medical item and system housing employed. For example, the heightof leg 882 may vary to accommodate different sized system housings,while the width of the guides may vary to accommodate varying sizedmedical items. By way of example only, the guides of FIGS. 28A-28B mayaccommodate liter solution bags and include thinner dimensions thanthose of the guides in FIGS. 28C-28D which may accommodate half litersolution bags. The thinner dimensions of the guides in FIGS. 28A-28Benable a greater distance or larger dimensioned channel to residebetween the guides to accommodate larger solution bags. Conversely, thethicker dimensions of the guides in FIG. 28C-28D enable a lesserdistance or smaller dimensioned channel to reside between the guides toaccommodate smaller solution bags. Similarly, the guides of FIGS. 28Aand 28C include greater heights than those of the guides of FIGS. 28Band 28D in order to accommodate a taller housing. The guides areinserted into system 800 each toward a respective side wall, where eachfoot 884 resides on and contours the heating plate with a correspondingleg 882 extending therefrom toward the housing top wall. The distancebetween the guides provides a channel to maintain proper orientation ofmedical items within the system as described above.

An exemplary control circuit for system 800 is illustrated in FIG. 29.Specifically, control circuit 885 includes power conductors 801, 803,ground 807, power switch 843, controller 845, solid state relay 805,limit switch 865, heater 858 and temperature sensors 872, 886, each asdescribed above. The circuitry further includes timer 860, a time delayrelay 808, a reset relay 811 and a power source 809. Power conductors801, 803 each include a respective fuse 815, 817 (e.g., a conventional 2amp fuse) that is arranged in series with power switch 843 to preventpower surges from damaging the switch and circuitry. Power switch 843controls power to the circuitry and is connected to the controller,solid state relay, power source and heater. The power switch may includea light to illuminate the switch. Controller 845 is further connected tosolid state relay 805 and temperature sensors 872, 886. The controllercontrols power applied to the heater via relay 805 in accordance with acomparison of a temperature measured by temperature sensor 872 and adesired temperature entered into the controller by a user. Inparticular, controller 845 receives temperature signals from temperaturesensor 872 indicating the temperature of a medical solution container incontact with the sensor (i.e., the container disposed on the heatingplate surface). In response to the temperature measured by temperaturesensor 872 being equal to or exceeding a desired temperature entered bya user, the controller disables power to the heater via solid staterelay 805. Conversely, when the temperature measured by temperaturesensor 872 is below the desired temperature, the controller enablespower to the heater via the solid state relay.

Limit switch 865 is connected between power source 809 and reset relay811 and facilitates control of the heater and timer in accordance withthe presence of a medical solution container within the system. Thepower source is further connected to timer 860, while time delay relay808 is connected to reset relay 811, controller 845 and solid staterelay 805. The reset and time delay relays may be implemented by anyconventional or other relay type devices. Basically, the limit switchenables the time delay and reset relays to control the timer and powerto the heater. When a medical solution container is present on theheating plate, the limit switch is in a closed state as described above.Accordingly, the connection between the power source and reset relay isenabled. The reset relay controls the reset of timer 860. The timerbasically resets when the reset line is low or grounded. Thus, when amedical item is removed from the heating plate and the limit switchenters an open state, the reset relay does not receive power from thepower source and provides a low signal to the timer reset line, therebyfacilitating a timer reset. When the limit switch enters a closed statedue to the presence of a new medical solution container on the heatingplate, the reset relay receives power signals from the power source,thereby providing a high signal to the timer reset line enabling thetimer to operate. The reset relay further energizes the time delay relaywhich prevents solid state relay 805 from enabling the heater for apredetermined time interval. Preferably, the delay time interval isapproximately 7.5 minutes, however, the time interval may be set to anydesired interval. The time delay enables the temperature of temperaturesensor 872 to approach the temperature of a new medical item received onthe heating plate to enhance temperature measurement. Basically, thetemperature of the temperature sensor is elevated due to contact with awarmed medical item. When the warmed medical item is removed from thesystem, the temperature sensor maintains the elevated temperature for ashort interval. Thus, the temperature sensor in this state may provideelevated temperature readings relative to the actual temperature of anew unwarmed medical item placed on the heating plate. The time delayenables the temperature sensor to cool and provide accurate temperaturemeasurements. Once the time delay interval has expired, time delay relay808 enables the solid state relay to control the heater in accordancewith control signals from the controller as described above.

When a medical solution container is removed or absent from the heatingplate, the limit switch is in an open state and the connection betweenthe reset relay and power source is disabled. The reset relay does notreceive power and provides a low signal on the reset line of timer 860to reset the timer. Similarly, the time delay relay is without power andcannot energize solid state relay 805 to enable the heater. Thus, whenthe switch is in an open state indicating no medical item on the heatingplate, the timer is reset and the heater is disabled.

Temperature sensor 886 is connected to the controller to facilitatedisablement of the heater in response to detecting a temperature inexcess of a predetermined threshold as described above. Basically,temperature sensor 886 provides a temperature indication of the solutioncontainer, heater and/or heating plate to controller 845. The controllerdisables power to the heater via relay 805 in response to the measuredtemperature exceeding a predetermined threshold as described above.Control circuit 885 may alternatively be implemented by any conventionalcircuitry components performing the above described functions, and mayutilize a cut-off switch in place of temperature sensor 886 to disablethe heater in response to excessive temperatures as described above.

System 800 includes a configuration similar to that described above forsystem 100 and may include report unit 101 and/or usage control unit1001 coupled to controller 845 to generate, transmit and/or printreports and/or control system usage as described above for system 100.Heating compartment 804 may further include an interface 20 in the formof a wireless transmitter/receiver (e.g., RF, infrared, etc.), bar codescanner or connector or port to communicate with the medical item oridentify the medical item to system 800 for storage of monitoredinformation as described above.

Operation of system 800 is described with reference to FIGS. 27A, 27Cand 29. Specifically, a user selects one or more medical solutions(e.g., bags or bottles containing saline or IV solutions, antibiotics orother drugs, blood, etc.) for heating by the system and determines theappropriate temperature for the solution. The solution bags may includethe devices described above for solution bag 2. The system may bemounted on stand 890 and transported to a desired site. The usersubsequently activates power switch 843 and pivots top wall 818 to anopen state. The user may insert appropriately dimensioned guides 870,880 into the system in order to properly orient the medical items on theheating plate as described above. The selected solution containers areplaced into the system in stack relation with an initial containerdisposed on plate 850 as described above.

Top wall 818 is subsequently pivoted to a closed state and a desiredtemperature for the selected solutions is entered into controller 843via controller input devices or buttons 849. The medical solutionswithin the storage compartment may be viewed through window 864 asdescribed above. In response to placement of a container on the heatingplate bottom wall, the container engages temperature sensor 872 andcauses closure of limit switch 865. The switch closure provides aconnection between power source 809 and reset relay 811 that initiatesthe timer and energizes time delay relay 808. The time delay relaydisables the heater for the predetermined time interval as describedabove. Once the time delay interval has expired, solid state relay 805is enabled and controlled by the controller in accordance with signalsfrom temperature sensor 872 to enable or disable power to heater 858 asdescribed above. Timer 860 continuously displays the elapsed time tomedical personnel on timer display 862 as described above. The heaterapplies heat to the heating plate bottom wall, while heating plate sidewalls 854 conduct heat from bottom wall 852 to evenly distribute heat tothe initial container. A cut-out switch and/or temperature sensor 886may be employed to facilitate disablement of the heater in response toexcessive heater, heating plate and/or solution temperatures asdescribed above.

Controller 845 displays the temperature of the container as measured bytemperature sensor 872, and may alternatively display the desired or setpoint 11 temperature entered by the user. Moreover, system 800 maycollect and provide information or reports (e.g., FIGS. 12A-12I) and/orcontrol system usage as described above for system 100, where thereports or information can be transmitted to internal printer 110,controller display 847 and/or to a local or remote external device(e.g., printer, display, database, medical item, etc.) as describedabove.

In response to attaining the desired temperature, the initial containeris removed from the heating plate via door 830. The limit switchsubsequently enters an open state, thereby disabling the connectionbetween the power source and the reset relay. The reset relay provides alow signal to the timer, thereby resetting the timer and display. Asuccessive container is urged by gravitational forces and/or manuallymanipulated into position on the heating plate bottom wall. The limitswitch enters a closed state and initiates operation of the timer andtime delay to repeat the process for this container. The above processmay be repeated for subsequent containers stored in the system. Once thelast container is removed, the limit switch disables the heater untilanother container is placed on the heating plate as described above.

Still another temperature control system of the present invention forthermally treating and/or monitoring medical solution containers (e.g.,bags or bottles containing saline or intravenous (IV) solutions,antibiotics or other drugs, blood, etc.) or other medical items (e.g.,instruments, blankets, etc.) with direct measurement of medical itemtemperature and display of medical item residence time within the systemis illustrated in FIG. 30. Specifically, temperature control system 900includes a cabinet or system housing 904 with a series of heating trays908. Cabinet 904 is generally in the form of a rectangular box andincludes top and bottom walls 910, 912, side walls 914, 916, a frontdoor 928, a front panel 918 disposed above the door, a front wall 929and a rear wall 920. The cabinet door, front panel and top, bottom andfront walls are each substantially rectangular, while the side walls aregenerally rectangular with a truncated upper front corner portion. Topwall 910 extends from rear wall 920 for a distance less than thatbetween the rear wall and front door. Front panel 918 extends from thefront door upper edge to the front edge of top wall 910 and is tilted atan angle. The side edges of the tilted front panel follow along thetruncated upper front corners of side walls 914, 916. Front wall 929 isdisposed beneath front door 928 and extends to bottom wall 912. Thewalls, panels and door collectively define a cabinet interior.

Trays 908 are disposed within the cabinet interior and may be mountedtherein via any conventional or other mounting devices (e.g., rails,ledges, brackets, etc.). Each tray is preferably mounted in the systeminterior at a downward angle toward rear wall 920 and includes aplurality of heating assemblies 905, each with a heating plate 850 forreceiving and heating a medical item to a desired temperature asdescribed above. Heating assemblies 905 are substantially similar toheating assembly 835 described above for FIG. 27A, except that heatingplate bottom wall 852 has a curved or arcuate configuration. The heatingplate bottom wall side edges are attached to heating plate side walls854 to form a curved or generally ‘U’-shaped heating plate configurationas described above. By way of example only, system 900 includes fourheating trays 908 with each tray including four heating assemblies 905,thereby enabling heating of a maximum of sixteen medical items at onetime. However, the system may include any quantity of trays with eachtray including any quantity of heating assemblies with any sized heatingplates to accommodate various sized medical solution containers (e.g.,one liter, three liter, etc.) or other medical items. A tray divider orpartition 922 is typically disposed between adjacent assembly heatingplates on each tray. However, adjacent heating plates may be placedproximate each other without a divider, or the heating plates may beconstructed of or molded within a continuous sheet of conductivematerial and utilized with the heating assemblies in substantially thesame manner described above.

Door 928 includes a handle (not shown) typically disposed toward anintermediate section side edge. The handle may be implemented by anyconventional or other type of handle. Alternatively, the handle may bedisposed on the door at any suitable location. Door 928 generally pivotstoward and away from the cabinet, and is preferably constructed ofelectro-galvanized steel or other suitably sturdy material with anopening covered by a substantially transparent material, such as glassor plexiglass, to serve as a window to enable viewing of the medicalitems and maintain heat within the cabinet. Alternatively, the door maybe constructed of a transparent material (e.g., glass, plastic, etc.).The door, opening and transparent material may be of any size or shape.

Rollers or casters 919 are attached to the cabinet bottom wall with eachcaster disposed toward a corresponding cabinet bottom wall corner toenable the system to be transportable. The casters or rollers may be ofany quantity, may be implemented by any conventional or other types ofrollers or wheel-type structures, and may be disposed at any locationson the cabinet. Further, the cabinet may be constructed ofelectro-galvanized steel or other suitably sturdy material, and may beof any size or shape.

Trays 908 are generally disposed in vertical alignment within thecabinet interior. The trays may be of any shape or size and may beconstructed of any suitable materials. The system and trays may beconfigured to accommodate various sized medical items. By way of exampleonly, the system is configured to accommodate liter medical solutionbags. The heating plates each include a limit switch 865 (FIGS. 27A-27C)as described above to control heating and residence time measurement fora medical item. The limit switch includes temperature sensors 872, 886disposed on limit switch arm 875 as described above (FIG. 27A-27C) tomeasure medical item and excessive temperatures, respectively.

A common system controller 930 (FIG. 32) enables entry of a desired orset point temperature for each heating assembly and includes a display974 to display for each heating assembly the set point temperature,medical item temperature and current residence time of the medical itemplaced on that heating assembly. Thus, the system enables each heatingassembly to be individually controlled to the same or differenttemperature. The display further provides a visual indication for aheating assembly when excessive temperatures have been detected for thatheating assembly (e.g., an over temperature (e.g., an “overtemp”)indication) or when a medical item is not present on that heatingassembly (e.g., an “empty” or “reload” indication). Exemplary displayscreens are illustrated in FIGS. 31A-31B.

Display 974 is disposed toward an intermediate section of front panel918, while a control panel 975 is generally disposed in the front paneladjacent the display. The control panel includes input devices 976(e.g., keys, buttons, switches, etc.) to facilitate entry of information(e.g., enter or adjust set point temperature, switch between Fahrenheitand Celsius, etc.) and a power switch 940 to enable power to the system.Alternatively, display 974 may be implemented by a touch screen deviceto facilitate entry of information. Various indicators 977 are furtherdisposed adjacent display 974 to notify an operator of system conditions(e.g., power enabled, etc.).

The system controller is in communication with heat controllers 952(FIG. 33) each associated with a corresponding tray to individuallycontrol each of the tray heating assemblies and measure residence time.The system controller receives information entered by a user andtransfers that information to the heat controllers to facilitate controlof the heating assemblies. The heat controllers individually controleach heating assembly of a corresponding tray in accordance withactuation of a corresponding limit switch, measured temperatures fromcorresponding temperature sensors 872, 886 and the set point temperaturefor that assembly received from the system controller. The heatcontrollers further maintain the residence time of medical items on theheating assemblies of the corresponding tray and may store residencetime in memory in order to recover and maintain residence timemeasurements in the event of a power failure. The system controllerreceives the medical item temperature and residence time for the heatingassemblies from the heat controllers for display on display 974.Further, the heat controllers each report excessive temperaturedetections and the presence of medical items for heating assemblies ofthe corresponding tray to the system controller to facilitate display ofthe excessive temperature and reload indications for the heatingassemblies. In addition, the heat controllers illuminate heatingassembly indicators 954 (e.g., LED), each disposed on a tray 908proximate a corresponding heating assembly to indicate when a medicalitem on that heating assembly has attained or is near (e.g., within apredetermined or user-specified range from) the corresponding set pointtemperature.

Basically, when a medical item is placed on a heating plate and limitswitch as described above, the limit switch enters a closed state andenables a corresponding heat controller to begin measuring elapsed time.The elapsed time is sent to the system controller for display on display974, preferably in the format of hours, minutes and seconds. However,the elapsed time may be measured and/or displayed in any desired formator fashion (e.g., days, hours, minutes, seconds, etc.). The limit switchfurther facilitates a time delay, where the corresponding heatcontroller delays operation of the corresponding assembly heater for apredetermined time interval. This delay enables the temperature of acorresponding temperature sensor 872 to approach the medical itemtemperature to provide enhanced temperature measurements as describedbelow. The medical item temperature, excessive temperature detectionsand presence of the medical item for the heating assembly are furthersent to the system controller for display. When the medical item isremoved from the assembly heating plate, the limit switch enters an openstate, thereby causing the corresponding heat controller to reset thetime and disable heating. Thus, the display notifies medical personnelof the residence time, temperature and presence of medical items oncorresponding heating assemblies, where the residence time informationinforms medical personnel of the amount of time a medical item has beenwarmed. Since medical items typically have limits with respect towarming time, medical personnel may remove the warmed medical item priorto excessive heating of the medical item and reduction in effectiveness.Cabinet 904 may include any quantity of rollers, trays, heatingassemblies, power switches, displays, indicators, controllers andaccompanying control circuitry, while the cabinet components (e.g.,walls, door, panel, etc.) may be arranged in any fashion.

An exemplary control circuit for system 900 is illustrated in FIG. 32.Specifically, control circuit 990 includes power conductors 901, 902,ground 907, power switch 940, system controller 930, display 974, a backlight 932, a power source 934, input devices 976, indicators 977 andheat control circuits 950. The heat control circuits are each associatedwith a corresponding tray 908 (FIG. 30) to individually control theheating assemblies of that tray as described below. Controller 930 istypically in the form of a motherboard including a controller andaccompanying circuitry. However, the system controller may beimplemented by any conventional or other controller, processor and/orcircuitry. Power conductors 901, 902 each include a respective fuse 944,946 that is arranged in series with power switch 940 to prevent powersurges from damaging the switch and circuitry. Power switch 940 controlspower to the circuitry and is connected to the power source. The powerswitch is further connected to the heat control circuits via aconnection terminal 942.

Controller 930 is connected to power source 934, back light 932, display974, input devices 976 and indicators 977. Further, the systemcontroller is connected to (not shown) or in communication with heatcontrollers 952 of heat control circuits 950, where the communication orconnection may be implemented in any desired fashion (e.g., wires,busses, etc.). The power source provides appropriate power signals(e.g., 12V DC) to the system controller, while the back light iscontrolled by controller 930 to provide suitable lighting conditions forthe display. The system controller receives user information from inputdevices 976 and illuminates appropriate indicators 977 based on the userinformation and system conditions (e.g., power enabled, etc.). Set pointtemperature and other information received by the system controller aredistributed to heat control circuits 950 to facilitate heating ofmedical items as described below. The system controller receivesresidence time, medical item temperature and other information (e.g.,excessive temperature detection, presence of a medical item, etc.) fromthe heat control circuits and controls display 974 to displayinformation (e.g., residence time, medical item temperature, excessivetemperature detections, reload or empty indications, etc.) for theheating assemblies. The display is generally partitioned into sectionswith each section associated with a corresponding heating assembly(e.g., the location of a section on the display corresponds to theposition of the associated heating assembly within the cabinet) toprovide information pertaining to that assembly (FIGS. 31A-31B). Theheating assemblies may each be associated with an identifier thatappears on the display to associate displayed information with acorresponding heating assembly. However, the display may be arranged inany fashion to provide information to an operator.

An exemplary heat control circuit 950 is illustrated in FIG. 33.Specifically, heat control circuit 950 receives information from systemcontroller 930 to control the heating assemblies of a corresponding tray908 (FIG. 30). The heat control circuit includes a heat controller 952and further includes limit switch 865, heater 858 and temperaturesensors 872, 886 of each heating assembly of the corresponding tray. Theheat controller is preferably in the form of a daughterboard with acontroller and accompanying circuitry. However, the heat controller maybe implemented by any conventional or other controller, processor and/orcircuitry. The limit switch, heater and temperature sensors aresubstantially similar to the ones described above. The heat controlcircuit further includes indicators 954 each associated with a heatingassembly of the corresponding tray to indicate when a medical itemtemperature of that heating assembly has attained or is near thecorresponding set point temperature.

Controller 952 is connected to temperature sensors 872, 886, heaters858, limit switches 865 and indicators 954 of the tray heatingassemblies. The controller controls power applied to a heating assemblyheater in accordance with a comparison of a temperature measured by acorresponding temperature sensor 872 and a desired temperature enteredfor that heating assembly and received from system controller 930. Inparticular, controller 952 receives temperature signals from a heatingassembly temperature sensor 872 indicating the temperature of a medicalsolution container in contact with the sensor (i.e., the containerdisposed on the heating plate surface). In response to the temperaturemeasured by the temperature sensor being equal to or exceeding a desiredtemperature entered by a user for that heating assembly, the controllerdisables power to the corresponding heater. Conversely, when thetemperature measured by the temperature sensor is below the desiredtemperature, the controller enables power to the corresponding heater.

Limit switches 865 of the corresponding tray heating assemblies are eachconnected to controller 952 and facilitate control of a correspondingheater and residence time measurement in accordance with the presence ofa medical solution container on a corresponding heating assembly.Controller 952 monitors the state of the limit switches. For example,this may be accomplished by sending a signal to each switch via arespective circuit and determining the presence of a return signal fromthat switch. If a limit switch is in a closed state, the respectivecircuit is completed and the return signal may be detected. When amedical solution container is initially placed on a heating plate, thecorresponding limit switch enters a closed state as described above.Accordingly, the heat controller senses this condition and commencesmeasuring elapsed time for the medical item of that heating assembly.The heat controller may store the elapsed time in memory in order torecover and maintain the residence time measurement in the event of apower failure.

The heat controller further prevents enablement of the correspondingheater for a predetermined time interval in response to the limit switchclosure. Preferably, the delay time interval is approximately fiveminutes, however, the time interval may be set to any desired interval.The time delay enables the temperature of a corresponding temperaturesensor 872 to approach the temperature of a new medical item received onthe heating plate to enhance temperature measurement. Basically, thetemperature of the temperature sensor is elevated due to contact with awarmed medical item. When the warmed medical item is removed from thesystem, the temperature sensor maintains the elevated temperature for ashort interval. Thus, the temperature sensor in this state may provideelevated temperature readings relative to the actual temperature of anew unwarmed medical item placed on the heating plate. The time delayenables the temperature sensor to cool and provide accurate temperaturemeasurements. Once the time delay interval has expired, controller 952controls the corresponding heater as described above.

When the medical item is removed from the heating plate and the limitswitch enters an open state, the heat controller detects this conditionand resets the time. Further, the heat controller disables thecorresponding heater. Thus, when the switch is in an open stateindicating no medical item on a heating plate, the timer is reset andthe corresponding heater is disabled.

Temperature sensors 886 of the heating assemblies of the correspondingtray are each connected to the heat controller to facilitate disablementof a corresponding heater in response to detecting a temperature inexcess of a predetermined threshold as described above. Basically,temperature sensor 886 of a heating assembly provides a temperatureindication of the corresponding solution container, heater and/orheating plate to controller 952. The heat controller disables power tothe corresponding heater in response to the measured temperatureexceeding a predetermined threshold as described above. The heatcontroller transfers the residence time, medical item temperature,excessive temperature detections and medical item presence informationfor each heating assembly of the corresponding tray to the systemcontroller for display on display 974 as described above. Thisinformation may be transmitted at any desired intervals for display bythe system controller. Control circuits 990 and 950 may alternatively beimplemented by any conventional circuitry components performing theabove described functions.

System 900 includes a configuration similar to that described above forsystem 100 and may include report unit 101 and/or usage control unit1001 coupled to system controller 930 to generate, transmit and/or printreports and/or control system usage as described above for system 100.Heating assemblies 805 may each further include an interface 20 in theform of a wireless transmitter/receiver (e.g., RF, infrared, etc.), barcode scanner or connector or port to communicate with a medical item oridentify the medical item to system 900 for storage of monitoredinformation as described above.

Operation of system 900 is described with reference to FIGS. 30-33.Specifically, a user selects one or more medical solutions (e.g., bagsor bottles containing saline or IV solutions, antibiotics or otherdrugs, blood, etc.) for heating by the system and determines theappropriate temperature for the solution. The solution container mayinclude the devices described above for solution bag 2. The system maybe transported to a desired site. The user subsequently activates powerswitch 940 and opens door 928. The selected solution containers areplaced into the system on any desired heating plates.

Door 928 is subsequently pivoted to a closed state and desiredtemperatures for the selected solutions are entered into the system viainput devices 976 as described above, where the solutions mayindividually be heated by the heating assemblies to the same ordifferent temperatures. The system controller transmits the set pointtemperature and other information to heat controllers 952 to controlheating and measurement of residence time. The medical solutions withinthe system may be viewed through the door. In response to placement of acontainer on a heating plate bottom wall, the container engagescorresponding temperature sensor 872 and causes closure of acorresponding limit switch 865. The switch closure is detected by acorresponding heat controller 952 and initiates measurement of elapsedtime and the time delay. The heat controller disables the correspondingassembly heater for the predetermined time interval as described above.Once the time delay interval has expired, the heat controller controlsthe corresponding heater (e.g., enables or disables power to the heater)in accordance with signals from corresponding temperature sensor 872 asdescribed above. The heater applies heat to the corresponding heatingplate bottom wall, while the heating plate side walls conduct heat fromthe bottom wall to evenly distribute heat to the container. Acorresponding temperature sensor 886 may be employed to facilitatedisablement of the heater in response to excessive heater, heating plateand/or solution temperatures as described above.

Heat controllers 952 transfer the residence time, medical itemtemperature, excessive temperature detection, medical item presence andother information for the heating assemblies to system controller 930for display on display 974 (FIGS. 31A-31B). When a medical item on aheating assembly attains or is near a desired temperature, the heatcontroller illuminates a corresponding indicator 954 as described above.Moreover, system 900 may collect and provide information or reports(e.g., FIGS. 12A-12I) and/or control system usage as described above forsystem 100, where the reports or information can be transmitted tointernal printer 110, display 974 and/or to a local or remote externaldevice (e.g., printer, display, database, medical item, etc.) asdescribed above.

In response to attaining the desired temperature, the container isremoved from a heating plate via door 928. The corresponding limitswitch subsequently enters an open state, thereby resetting the timer,disabling the corresponding heater and enabling display of a reload orempty indicator for that heating assembly. A new container may be placedon that heating plate, where the limit switch enters a closed state andinitiates residence time measurement, delayed heating and display ofinformation to repeat the process for this container. The above processmay be repeated for additional containers or medical items. A user mayutilize any quantity or combination of heating assemblies in any fashion(e.g., within the same or different trays) to heat medical items withinthe system.

In order to further assist medical personnel or users in complying withthe prescribed requirements for solution bag 2 or other medical item,the present invention enables marking of the solution bag with conditioninformation as illustrated in FIG. 34. In particular, the presentinvention includes placing time stamp information (e.g., time and/ordate, the patient, solution and/or facility information described above,etc.) on a medical item 1102 (e.g., medical solution containers or bags,etc.) including insertion and/or removal times of the item within athermal treatment system (e.g., a heating and/or cooling system). Thetime stamp information may be directly placed on the medical item or beimprinted on a label for attachment to the item as described below. Thepresent invention enables users to readily determine medical itemcompliance with regulatory and medical item manufacturer requirementsrelating to medical item heating time, temperature and/or otherconditions in order to ensure patient safety.

Specifically, system 1100 includes a marking device 1150 and thermaltreatment system 100. The thermal treatment system may be of any of thetypes of systems described above, especially those accommodatingsolution bags (e.g., FIGS. 10-11, 13-15, 18, 22, 27A and 30). Themarking device produces and places time stamp information on medicalitem 1102 as described below. The medical item may include any of thedevices described above for solution bag 2. The placement of informationon the medical item occurs prior to insertion of the medical item withinthe thermal treatment system. The time stamp information basicallypertains to the time the medical item is inserted within the thermaltreatment system. Thermal treatment system 100 thermally treats themedical item as described above, where the time stamp informationincludes the medical item insertion time, thereby enabling users todetermine the time interval that the medical item has been thermallytreated. This ensures that the medical item is treated for anappropriate time interval to maintain the medical item efficacy asdescribed above. The medical item may further receive time stampinformation from the marking device upon removal from the thermaltreatment system, thereby providing a record of the thermal treatmenttime interval (e.g., the time stamp information includes the insertionand removal times) and enabling medical personnel to readily determinethe time by which the medical item must be utilized. The marking devicemay be implemented as a stand-alone device or may be attached to orintegral with the thermal treatment system.

System 1100 may be used at any location where medical items are used(e.g., the operating room, emergency room, Pre OP, Post OP, patient'sroom, home, nursing home, etc.). It is to be understood that the presentinvention marking system may be utilized with or employ any type ofthermal treatment system, such as the ones described above and disclosedin the aforementioned patents, patent publications and patentapplications. The present invention marking system is especiallysuitable for those thermal treatment systems measuring medical itemresidence time, thereby providing time stamp and residence timeinformation to users or medical personnel to further ensure appropriatethermal treatment intervals for medical items.

Medical item 1102 (FIG. 34) is preferably an intravenous solution bag,but may be a wide variety of medical items (e.g., medical solutioncontainers, saline solutions, IV solutions and/or lines, instruments,blankets, antibiotics or other drugs, blood, irrigation fluid and/orlines, etc.). An exemplary medical item in the form of an intravenoussolution bag for use with the present invention and having time stampinformation placed thereon is illustrated in FIG. 35A. Specifically,intravenous solution bag 1102 is similar to the bags described above andis preferably implemented by a conventional intravenous solution bagconstructed of plastic or other materials commonly utilized for formingthose types of bags. The solution bag may contain various types ofsolutions, such as saline solution, blood, antibiotic or other drugs, orany other intravenously administered solution. Intravenous solution bag1102 further includes generally triangular projection 4 attached to andextending from the bag upper portion. Projection 4 preferably includes atruncated upper portion having opening or hole 6 defined therein forinterfacing an intravenous pole or other support structure (not shown)as described above. The bag lower portion includes outlet 7 andassociated fluid conduits 15 to interface an intravenous tube (notshown) and enable the solution to flow through the tube from the outletto a patient as described above.

Generally, intravenous solutions are required to be within a specifictemperature range during infusion to avoid injury to a patient asdescribed above. The solutions typically have a prescribed heating timeand utilization life in order to maintain their efficacy as describedabove. The present invention marking system provides time stampinformation for placement on the bag in order to ensure compliance withprescribed requirements (e.g., appropriate heating intervals, etc.).Specifically, time stamp information 1110 may be placed directly on thebag. This may be accomplished by any conventional or other techniques(e.g., a physical impression on the solution bag (with or without ink),a printed indicator by dot matrix, laser printing or thermal techniques,etc.).

Alternatively, time stamp information 1110 can be printed onto aself-adhesive label to be adhered to the solution bag. This labelreceives time stamp information and is adhered to the bag prior to thebag being placed in the thermal treatment system. The label adhesive maybe sufficiently strong to prevent removal of the label from the bagand/or label tampering. The strength of the label adhesive mayalternatively enable a user to remove the label from the bag forattachment to a chart. The label may be of any size or shape and may beof any type of printing material (e.g., paper, thermal paper, fabric,etc.). Further, the label may include areas or fields to receivespecific time stamp information from the marking device (e.g., entrytime into the thermal treatment system, removal time, date, the facilityinformation described above, solution and/or patient, etc.). By way ofexample only, the time stamp information is placed on the bag adjacentprojection 4, however, the time stamp information may be disposed at anylocation on the bag and be arranged in any fashion to cover areas of anysize or shape.

Intravenous solution bag 1102 may alternatively be encased in a liner oroverwrap as illustrated in FIG. 35B. Specifically, intravenous solutionbag 1102 is substantially similar to the solution bag described abovefor FIG. 35A, except that the solution bag is disposed within a liner oroverwrap 1114. Liner 1114 may be constructed of any type of plastic orother suitable materials (e.g., materials of the type utilized to formthe solution bag), and preferably has dimensions slightly greater thanthe dimensions of solution bag 2 to receive and house the solution bag.Liner 1114 is preferably sealed along its edges via any conventional orother fastening techniques. The time stamp information may be placeddirectly on the liner via any conventional or other techniques (e.g., aphysical impression on the liner, a printed indicator by dot matrix,laser printing or thermal techniques, etc.) as described above.Alternatively, time stamp information 1110 can be printed onto aself-adhesive label to be adhered to the liner as described above. Byway of example only, the time stamp information is placed on the linertoward projection 4, however, the time stamp information may be disposedat any location on the liner.

An exemplary marking device employed by the present invention isillustrated in FIG. 36. Specifically, marking device 1150 includes ahousing (not shown) including a processor 1152, a display 1156, anarticle sensor or switch 1158, input devices 1160 and a marking orprinting unit 1162. Processor 1152 may be implemented by anyconventional or other microprocessor and controls device operation. Theprocessor further maintains time stamp information (e.g., time, date,etc.) for placement on a medical item. The processor is coupled to inputdevices 1160 typically disposed on the housing exterior to receiveinformation entered by a user. This information may include time and/ordate settings, various device parameters and any desired information forthe time stamp information (e.g., the facility, patient and/or solutioninformation described above, type of item, etc.). Input devices 1160 maybe implemented by any conventional or other input devices (e.g.,buttons, keys, switches, keypad, etc.). Display 1156 is coupled toprocessor 1152 and may be implemented by any conventional or otherdisplay (e.g., LED, LCD, etc.). The display is typically disposed on thehousing exterior and may provide any desired information to a user(e.g., time stamp information, current date and/or time, etc.).

The marking device housing includes a marking area enabling switch 1158and printing unit 1162 to engage an article (e.g., medical item orlabel) for receiving time stamp information. In particular, switch 1158is coupled to processor 1152 and may be implemented by any conventionalor other sensor or switch. The switch provides a signal to the processorto indicate the presence of an article within the marking area toreceive time stamp information. Basically, an article is positioned inthe marking area to receive time stamp information from the printingunit. The switch is disposed in the marking area in a manner thatenables the article to actuate the switch in response to the articlepositioning. The switch provides a signal to the processor to initiatemarking of the article as described below.

Processor 1152 is further coupled to printing unit 1162. The printingunit may be implemented by any conventional or other devices capable ofplacing the time stamp information on the article. For example, theprinting unit may be implemented by a conventional printer to print thetime stamp information on the article (e.g., via conventional dotmatrix, ink jet, laser printing, and/or thermal printing techniques).Alternatively, the printing unit may be implemented by devicesimprinting or impressing (with or without ink) the time stampinformation onto the article surface. This may be accomplished viaconventional laser or thermal techniques or plate type impressions ontothe article. Processor 1152 receives the signal from switch 1158 andinitiates the printing unit to place the time stamp information on thearticle. The time stamp information (or any portion thereof) may furtherbe printed or marked in the form of a bar code or other indicator toenable this information to be scanned for entry into a computer or othersystem for processing.

Marking device 1150 may alternatively be implemented by any conventionalor other marking devices providing time stamp information, such as aPix-15 available from Amano Electronics, Inc. and the types of devicesdisclosed in U.S. Pat. Nos. 6,061,303 (Gauthier et al) and U.S. Pat. No.6,527,462 (Arledge et al), the disclosures of which are incorporatedherein by reference in their entireties.

The time stamp information may include any desired information and maybe arranged in any desired format. Typically, the time stamp informationincludes at least the year, day of the year (e.g., month and day) andtime of day. The time stamp information may be in the form of text andread by an operator and/or in the form of a bar code or other indicatorfor scanning by a reader as described above. Labels with time stampinformation are illustrated, by way of example only, in FIGS. 37A-37B.Specifically, the labels include an area or field for the time stampinformation and are typically pre-printed with descriptive information(e.g., Time/Date In, Time/Date Out, etc.) adjacent the field to indicateto a user the relevancy of the time stamp information. For example, thelabel in FIG. 37A includes descriptive information (e.g., Time/Date In)indicating that time stamp information 1110 pertains to the insertiontime of a medical item into a thermal treatment system. The label ofFIG. 37B includes descriptive information (e.g., Time/Date Out)indicating that time stamp information 1110 pertains to the removal timeof the medical item from the thermal treatment system. The time stampinformation produced by the marking device includes the year (e.g., in a'YY format (an apostrophe followed by the last two digits of the year)),month (e.g., in a MMM format (the first three letters of the month)),day of the month (e.g., in a DD format (one or two digits)) and time(e.g., with an AM/PM indication followed by an HH:MM format (one or twodigits for the hour and two digits for the minutes)). However, the timestamp information may be presented in any desired formats. The timestamp information is placed on each article (e.g., medical item orlabel) presented to the marking device for marking.

The labels may include any desired quantity of fields with any type ofdescriptive information. Alternatively, the labels may be blank, wherethe marking device provides the time stamp and descriptive information.The descriptive information may be provided pre-printed on the label orby the marking device in any combination. Further, the labels may bepresented to the marking device for receiving time stamp information,where the stamped labels may subsequently be adhered to the medical itemby the user via various techniques (e.g., adhesive, fastener,self-adhesive label, etc.). Alternatively, the medical item may includethe label already attached and be presented to the marking device toreceive the time stamp information. In addition, the medical item mayinclude any descriptive information and/or fields and may directlyreceive the time stamp information from the marking device (e.g., viaprinting or impression techniques) at any desired locations as describedabove.

Operation of the system is described with reference to FIG. 34.Specifically, medical item 1102, preferably a solution bag, is initiallyretrieved for a medical procedure. The bag may include any of thedevices or indicia described above for solution bag 2. The bag istypically required to have the desired utilization temperature prior touse as described above. When the bag requires thermal treatment toattain the desired utilization temperature, the bag is received bymarking device 1150 at flow 1120. The marking device maintains timestamp information (e.g., time, date, the facility, patient and/orsolution information described above, etc.) and may place any desiredinformation (e.g., typically time and date information) directly on thebag as described above. Alternatively, the marking device may place thisinformation on a label for attachment to the bag as described above.

Once the time stamp information has been placed on the bag, the bag isdisposed within thermal treatment system 100 at flow 1122. The timestamp information placed on the bag basically pertains to the time thebag is placed in the thermal treatment system. The thermal treatmentsystem is operated to thermally treat the bag to a desired temperaturesuitable for use in the medical procedure as described above. Themedical item and/or thermal treatment system may measure, collect,transmit and/or print medical solution information locally or externallyas described above. The time stamp information enables users todetermine the heating or residence time of the bag within the system inorder to ensure the bag is heated for an appropriate time interval tocomply with prescribed procedures and maintain its efficacy.

When the bag has attained a desired temperature, the bag is removed fromthermal treatment system 100 for utilization in the medical procedure.Alternatively, the bag may be removed from the thermal treatment systemand be received by marking device 1150 at flow 1124 in order to providefurther time stamp information on the bag (or label) pertaining toremoval of the bag from the thermal treatment system. This additionaltime stamp information provides a record of the bag heating time.

The present invention thus provides monitoring conditions of medicalsolution or other medical items at each and/or any stage during the lifeof that item from manufacture to disposal (e.g., from manufacturing,through storage prior to and/or during transport, through storage at anintended facility, through thermal treatment at a facility, etc.).Accordingly, the precise status of the medical solution with respect toprescribed requirements (e.g., medical regulations or standards,manufacturer requirements, etc.) may be indicated to users and/ormedical personnel to prevent non-compliant items from being utilized oradministered to patients.

It will be appreciated that the embodiments described above andillustrated in the drawings represent only a few of the many ways ofimplementing medical item thermal treatment systems and method ofmonitoring medical items for compliance with prescribed requirements.

The present invention medical items and thermal treatment systems may beutilized individually or in any combination to monitor any types ofmedical items for compliance with any types of requirements (e.g.,manufacturer, medical personnel, medical standard or regulation, etc.).The present invention may monitor the items and/or indicate the status(e.g., compliance or non-compliance with prescribed requirements) to anyusers or medical personnel through each or any of the stages of themedical item life (e.g., from manufacture through use and/or disposal).

The monitoring device may be of any quantity, shape or size and may bedisposed at any location on or within the medical item via anyconventional or other techniques (e.g., adhesive, welding, lamination,floatation devices for placement in solution, etc.). The monitoringdevice may include any quantity of any types of conventional or othersensors (e.g., proximity sensors, pressure sensors, temperature sensors(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volumesensors, flow sensors, fluid sensors, fluid level sensors, etc.) tomeasure and provide any information. The processor may be implemented byany conventional or other microprocessor. Software for the processor maybe implemented in any desired computer language and could be developedby one of ordinary skill in the computer arts based on the functionaldescriptions contained herein. The processor may alternatively beimplemented by any type of hardware, software and/or other processingcircuitry, and may be available pre-programmed for immediate use. Thevarious functions of the processor may be distributed in any manneramong any quantity of software modules, processors and/or circuitry. Thealgorithms and/or processes described above may be modified in anymanner that accomplishes the functions described herein.

The monitoring device may compare measured values or other informationto any desired requirements to indicate compliance with thoserequirements. For example, the monitoring device may examine the recordof medical item conditions and determine and/or indicate that themedical item has been previously warmed (e.g., based on recordedtemperatures) to prevent re-warming of the medical item. Further, themonitoring device may determine and/or indicate when the medical itemhas been inserted into and/or removed from a thermal treatment system(e.g., based on temperature variations in the record) and/or thesubsequent time within which the item must be used (e.g., medical itemsmay have a use time after thermal treatment). Moreover, the monitoringdevice monitors medical item conditions during storage (or non-use) toensure that higher temperature exposure does not accelerate changes inthe item (e.g., efficacy) and/or that the medical item remainspharmaceutically acceptable. In addition, the monitoring device mayexamine fluid level information (e.g., in the record or as theinformation is being measured) to indicate the amount of fluid or when aparticular dosage has been administered. The monitoring device mayindicate any conditions on the display and/or indicators.

The display may be of any quantity, size or shape, may be implemented byany conventional or other display (e.g., LCD, LED, etc.) and may displayany desired information. The display may be disposed at any desiredlocation on the medical item and utilize any symbols or characters(e.g., alphanumeric, punctuation, icons, etc.) to indicate compliancewith conditions. The indicators may be of any quantity or type (e.g.,LEDs or other illuminating devices of any colors, etc.) and may bedisposed at any desired locations on the medical item. Any quantity ofindicators may be associated with a particular condition and may beilluminated or actuated in any fashion (e.g., brightness, flashing,colors, etc.) to indicate that condition. Further, the monitoring devicemay include any quantity of any type of visual and/or audio indicators(e.g., speech synthesis, beep, buzzer, etc.) to indicate conditions.

The interface may be implemented by any conventional or other interface(e.g., wireless, RF, infrared, cable, connector, etc.) and utilize anydesired protocol to communicate with an external device. The externaldevice may be in the form of any processing device (e.g., computersystem, hand-held receiver, PDA, etc.) to communicate with and retrieveinformation from the monitoring device. The external device may provideany desired information to the monitoring device (e.g., entered by auser, etc.). The external device may store retrieved information in anytype of storage unit (e.g., file, local or remote database or othermemory or storage unit, etc.) for access by users for any desiredpurposes (e.g., tracking, inventory, reviewing item history, etc.). Themonitoring device may include any type of location devices (e.g., GPS,homing device, transmitter, etc.) to provide location information forthe medical item. The monitoring device may utilize any quantity of anytype of power source (e.g., batteries, etc.) and may include a uniqueidentifier of any desired length of any types of characters or symbols(e.g., alphanumeric, etc.). The monitoring device may be disposable withthe medical item or re-programmed for use with subsequent medical items.

The memory device may be of any quantity, shape or size and may bedisposed at any location on or within the medical item via anyconventional or other techniques (e.g., adhesive, welding, lamination,floatation devices for placement in solution, etc.). The memory deviceprocessor may be implemented by any conventional or othermicroprocessor. Software for the processor may be implemented in anydesired computer language and could be developed by one of ordinaryskill in the computer arts based on the functional descriptionscontained herein. The processor may alternatively be implemented by anytype of hardware, software and/or other processing circuitry, and may beavailable pre-programmed for immediate use. The various functions of theprocessor may be distributed in any manner among any quantity ofsoftware modules, processors and/or circuitry. The algorithms and/orprocesses described above may be modified in any manner thataccomplishes the functions described herein.

The processor may compare measured values or other information to anydesired requirements to indicate compliance with those requirements. Forexample, the memory device may examine the record of medical itemconditions and determine and/or indicate that the medical item has beenpreviously warmed (e.g., based on recorded temperatures) to preventre-warming of the medical item. Further, the memory device may determineand/or indicate when the medical item has been inserted into and/orremoved from a thermal treatment system (e.g., based on receivedinformation or temperature variations in the record) and/or thesubsequent time within which the item must be used (e.g., medical itemsmay have a use time after thermal treatment). Moreover, the memorydevice enables monitoring of medical item conditions to ensure thathigher temperature exposure does not accelerate changes in the item(e.g., efficacy) and/or that the medical item remains pharmaceuticallyacceptable. The memory device may indicate any conditions on the displayand/or indicators.

The memory device display may be of any quantity, size or shape, may beimplemented by any conventional or other display (e.g., LCD, LED, etc.)and may display any desired information. The display may be disposed atany desired location on the medical item and utilize any symbols orcharacters (e.g., alphanumeric, punctuation, icons, etc.) to indicatecompliance with conditions. The memory device indicators may be of anyquantity or type (e.g., LEDs or other illuminating devices of anycolors, etc.) and may be disposed at any desired locations on themedical item. Any quantity of indicators may be associated with aparticular condition and may be illuminated or actuated in any fashion(e.g., brightness, flashing, colors, etc.) to indicate that condition.Further, the memory device may include any quantity of any type ofvisual and/or audio indicators (e.g., speech synthesis, beep, buzzer,etc.) to indicate conditions.

The memory device interface may be implemented by any conventional orother interface (e.g., wireless, RF, infrared, cable, connector, etc.)and utilize any desired protocol to communicate with an external device.The external device may be in the form of any processing device (e.g.,thermal treatment system, computer system, hand-held receiver, PDA,etc.) to communicate with and retrieve and/or provide information. Theexternal device may provide any desired information to the memory device(e.g., entered by a user, etc.). The external device may further storeinformation in any type of storage unit (e.g., file, local or remotedatabase or other memory or storage unit, etc.) for access by users forany desired purposes (e.g., tracking, inventory, reviewing item history,etc.). The memory device may utilize any quantity of any type of powersource (e.g., batteries, etc.) and may include a unique identifier ofany desired length of any types of characters or symbols (e.g.,alphanumeric, etc.). The memory device may be disposable with themedical item or re-programmed for use with subsequent medical items.

The bar code and/or transponder unit may be of any quantity, shape orsize and may be disposed at any location on or within the medical itemvia any conventional or other techniques (e.g., adhesive, welding,lamination, floatation devices for placement in solution, etc.). Thetransponder unit processor may be implemented by any conventional orother microprocessor. Software for the processor may be implemented inany desired computer language and could be developed by one of ordinaryskill in the computer arts based on the functional descriptionscontained herein. The processor may alternatively be implemented by anytype of hardware, software and/or other processing circuitry, and may beavailable pre-programmed for immediate use. The various functions of theprocessor may be distributed in any manner among any quantity ofsoftware modules, processors and/or circuitry. The algorithms and/orprocesses described above may be modified in any manner thataccomplishes the functions described herein.

The transceiver may be implemented by any conventional or othertransceiver (e.g., wireless, RF, infrared, cable, connector, etc.) tocommunicate with the thermal treatment system or other external device(e.g., processing device or system, computer system, hand-held receiver,PDA, etc.). The thermal treatment system or other external device mayprovide any desired information to the transponder unit (e.g., enteredby a user, etc.). The thermal treatment system or other external devicemay store information in any type of storage unit (e.g., file, local orremote database or other memory or storage unit, etc.) for access byusers for any desired purposes (e.g., tracking, inventory, reviewingitem history, etc.). The thermal treatment system or other externaldevice may compare measured values or other information to any desiredrequirements to indicate compliance with those requirements. Forexample, the thermal treatment system or other external device mayexamine the record of medical item conditions and determine and/orindicate that the medical item has been previously warmed (e.g., basedon recorded temperatures) to prevent re-warming of the medical item.Further, the thermal treatment system or other external device maydetermine and/or indicate when the medical item has been inserted intoand/or removed from a thermal treatment system (e.g., based oninformation from the thermal treatment system or temperature variationsin the record) and/or the subsequent time within which the item must beused (e.g., medical items may have a use time after thermal treatment).Moreover, the thermal treatment system or other external device monitorsmedical item conditions to ensure that higher temperature exposure doesnot accelerate changes in the item (e.g., efficacy) and/or that themedical item remains pharmaceutically acceptable. The thermal treatmentsystem or external device may indicate any conditions via a displayand/or indicators. The thermal treatment system or external device mayinclude any quantity of any type of visual and/or audio indicators(e.g., speech synthesis, beep, buzzer, etc.) to indicate conditions.

The transponder unit may utilize any quantity of any type of powersource (e.g., batteries, etc.). The bar code and transponder unit mayprovide a unique identifier of any desired length of any types ofcharacters or symbols (e.g., alphanumeric, etc.). The transponder unitmay be disposable with the medical item or re-programmed for use withsubsequent medical items.

The ink cells may be of any quantity of any type of conventional orother ink cells. The ink cells may be disposed at any desired locationson the medical item in any desired arrangement. The cells mayalternatively be disposed in any fashion on any quantity of labels ofany shapes or sizes and adhered or disposed on the medical item at anydesired locations. Any quantity of cells may be associated with aparticular condition and may be activated in any fashion (e.g., changecolors, dark to light, light to dark, etc.) to indicate that condition.The ink cells may be utilized to indicate any desired conditions.

The control circuit may be disposed on or remote from the medical item.The control circuit or external device (e.g., thermal treatment system,processing system or device, transport container or housing, etc.) mayinclude any quantity of any types of conventional or other sensors(e.g., proximity sensors, pressure sensors, temperature sensors (e.g.,RTD, infrared, etc.), presence sensors, weight sensors, volume sensors,flow sensors, fluid sensors, fluid level sensors, etc.) to measure andprovide any information. The control circuit processor may beimplemented by any conventional or other microprocessor. Software forthe processor may be implemented in any desired computer language andcould be developed by one of ordinary skill in the computer arts basedon the functional descriptions contained herein. The processor mayalternatively be implemented by any type of hardware, software and/orother processing circuitry, and may be available pre-programmed forimmediate use. The various functions of the processor may be distributedin any manner among any quantity of software modules, processors and/orcircuitry. The algorithms and/or processes described above may bemodified in any manner that accomplishes the functions described herein.

The processor may compare measured values or other information to anydesired requirements to indicate compliance with those requirements. Forexample, the control circuit (or external device) may examine the recordof medical item conditions and determine and/or indicate (e.g., via theink cells) that the medical item has been previously warmed (e.g., basedon recorded temperatures) to prevent re-warming of the medical item.Further, the control circuit (or external device) may determine and/orindicate (e.g., via the ink cells) when the medical item has beeninserted into and/or removed from a thermal treatment system (e.g.,based on information from a thermal treatment system or temperaturevariations in the record) and/or the subsequent time within which theitem must be used (e.g., medical items may have a use time after thermaltreatment). Moreover, the control circuit (or external device) maymonitor medical item conditions during storage (or non-use) to ensurethat higher temperature exposure does not accelerate changes in the item(e.g., efficacy) and/or that the medical item remains pharmaceuticallyacceptable. The control circuit (or external device) may indicate anyconditions on the display and/or indicators.

The clip may be implemented by any quantity of any type of connector toconnect the cells to the external device or control circuit. The clipmay be disposed at any location on the medical item. The cells may bemanually activated by any quantity of any type of actuator (e.g.,button, switch, etc.) disposed at any locations on or remote from themedical item. The ink cells and/or control circuit may utilize anyquantity of any type of power source (e.g., batteries, etc.).

Thermal treatment system 100 may include any conventional or otherheating and/or refrigeration units to thermally treat the medical itemsto any desired temperature. The monitoring sensors may be implemented byany quantity of any conventional or other sensors (e.g., proximitysensors, pressure sensors, temperature sensors (e.g., RTD, infrared,etc.), presence sensors, weight sensors, volume sensors, flow sensors,fluid sensors, fluid level sensors, etc.) to measure and provide anydesired information to the report controller and/or usage control unitand may be disposed at any location. The system may be powered by anyconventional or other power source (e.g., AC, DC, wall outlet jack,batteries, etc.).

The temperature controller may be implemented by any quantity of anyconventional or other temperature controller or processor (e.g., chip,card, processor, circuitry, etc.) and include any quantity of anydesired input devices (e.g., buttons, keypad, etc.). The temperaturecontroller may control the heater/cooler units to any desiredtemperature range, and may utilize any quantity of set points (e.g.,maximum and/or minimum, etc.). The system may record any type ofinformation (e.g., date and time of thermal treatment disablement andenablement, fluid level or loss, etc.) relating to system operation forsubsequent retrieval, analysis, display, display/report (e.g., date andtime of thermal treatment disablement and enablement, fluid level orloss, etc.) and control functions supported by the system.

The report controller may be implemented by any conventional or othermicroprocessor or controller (e.g., chip, card, processor, circuitry,etc.) and include any quantity of any desired input devices (e.g.,buttons, keypad, etc.). The report controller may maintain the date,elapsed heating/cooling time and/or occurrence time of any event orcondition (e.g., time medical items are inserted and/or removed withinthe system, etc.). The report controller may measure the elapsed time orrecord an occurrence time for any desired condition. The reportcontroller may maintain the time information internally or utilize anydesired external circuitry (e.g., a timer, etc.).

The report controller may collect any desired information (e.g., startdate and time of solution or other item heating/cooling, the timeinterval the solution or other item was heated/cooled, the temperaturethe solution or other item attained during heating/cooling, temperatureof the solution or other item when the solution was removed from thesystem, amount or quantity of solution or other item residing, placed inor removed from the system, partial or complete history of time andsolution or other item temperature measured at any desired timeintervals, facility information, patient information, doctorinformation, type of procedure, solution information, type ofinstruments or other item being heated/cooled, amount or quantity ofsolution or other item being heated/cooled, etc.) from any desiredsources (e.g., temperature controller, user, memory, another computer ordevice, etc.). The report controller may implement or be implemented bythe temperature controller. The monitoring sensors may be coupled to thetemperature controller, system interface and/or report controller eitherindividually or in any combination or fashion.

The reports may be arranged in any fashion and include any desiredinformation. The date, time and other information may be in any desiredformat (e.g., month, day and year, hours and minutes, text, numeric,icons, etc.). The report information may be arranged and/or presented(e.g., printed, displayed, etc.) in any desired formats (e.g., text,charts, graphs, columns, rows, tables, etc.) and in any order orarrangement. The graph may include any quantity of axes each associatedwith any desired information (e.g., time, temperature, etc.) in anydesired scales or units (e.g., Celsius, Fahrenheit, etc.). The graphsmay utilize any types of symbols or characters (e.g., dots, diamonds,dashes, alphanumeric characters, punctuation symbols, etc.) to indicatepoints on the graph. The graphs may indicate time, temperature or events(e.g., removal of solution, etc.) in any fashion. The reports mayprovide information (e.g., temperature, etc.) measured or collected atany desired preset or user specified time intervals (e.g., hours,minutes, seconds, etc.). The time intervals may be specified by a uservia any input devices (e.g., temperature or report controller inputdevices (e.g., keys, buttons, etc.), remote or local computer, etc.).The report and/or information may alternatively be stored in a local orremote database or memory device (e.g., local memory, removable memory,etc.) for later retrieval. The reports may include a pre-arranged formator may be programmable or selected by a user via report controller inputdevices. The system, controller and other displays may be of anyquantity, shape or size, may be disposed at any location on or remotefrom the system, may be implemented by any conventional or otherdisplays (e.g., LED, LCD, etc.) and may display any desired information.The information displayed may be selected via temperature controller orreport controller input devices, or the display may include displaycontrols (e.g., buttons, keys, etc.).

The internal printer may be implemented by any conventional or otherprinting device, may be local or remote, may serve any quantity ofsystems or other devices, and may produce reports on any desired medium(e.g., paper, labels, etc.). The reports may be printed and/or displayedconcurrently with system operation as report data is collected or at anyspecific time or in response to user entered information (e.g., a printcommand or key). The report may be printed at any desired time before,during or after system use, and may be retrieved from the system at anydesired time or in any desired manner that preserves a sterile field(e.g., after completion of the medical procedure, times when a sterilefield is not needed or being employed by the system, etc.). The systemor report controller may include any conventional or othercommunications device or module (e.g., modem, etc.) and may download ortransfer an electronic form of the report to any desired device (e.g.,PDA, computer, another system, etc.) at any specific time or in responseto user entered information (e.g., transmit command or key). The systemmay further be networked to enable retrieval of reports and/orinformation from a station coupled to the network. The printer anddisplays may be disposed at any suitable locations on or remote from thesystem. Alternatively, the system may be implemented to generate reportswithout the printer and/or display. Any desired information may betransmitted between the system components (e.g., temperature controller,report controller, printer, displays, etc.) via any conventional orother communications medium or protocols (e.g., hardwire, wireless,network, etc.).

Software for the temperature controller and report controller may beimplemented in any desired computer language and could be developed byone of ordinary skill in the computer arts based on the functionaldescriptions contained herein. The temperature controller and/or reportcontroller may alternatively be implemented by any type of hardwareand/or other processing circuitry, and may be available pre-programmedfor immediate use. The various functions of the temperature controllerand/or report controller may be distributed in any manner among anyquantity of software modules, processors and/or circuitry.

The system interface, computer interface and communications device ofthe usage control unit may be implemented by any quantity of anyconventional or other microprocessor or controller (e.g., chip, card,processor, circuitry, etc.) and include any quantity of any desiredinput devices (e.g., buttons, keypad, etc.). The computer interface maybe in the form of a read/write unit to transfer information to thecomputer system. The system and computer interfaces may be of anyquantity and accommodate any quantity of information devices. Thecommunications device may include any quantity of any conventional orother devices (e.g., modem, router, etc.) for communications with thenetwork or other devices. The system interface and communications devicemay maintain the date, elapsed heating/cooling time and/or occurrencetime of any event or condition (e.g., time medical items are insertedand/or removed within the system, etc.) and may measure the elapsed timeor record an occurrence time for any desired condition. The systeminterface and communications device may maintain the time informationinternally or utilize any desired external circuitry (e.g., a timer,etc.).

The system interface and communications device may collect any desiredinformation (e.g., the date/time that a medical item was placedinto/removed from the medical item warming/cooling system, thetemperature of the medical item upon being placed into/removed from themedical item warming/cooling system, the temperature of the medical itemat specific points in time while stored in the medical itemwarming/cooling system, start date and time that the medical item beganto be heated/cooled, the length of time that the medical item washeated/cooled, the temperature that the medical item was heated/cooledto during the heating/cooling cycle and/or the amount of solution orother item residing, placed in or removed from the system, patientinformation, thermal treatment system information (e.g., type,identification or serial number, etc.), user information (e.g., accessor account identification or code, passwords, etc.), facilityinformation, doctor information, the type of procedure, solutioninformation, the type of item being heated/cooled, the amount orquantity of fluid or other item being heated/cooled (e.g., fluid (orother item) level, volume or weight), the flow rate of fluid that isbeing heated/cooled, the pressure of fluid flow as the fluid isheated/cooled and any other desired information) from any desiredsources (e.g., temperature controller, user, memory, another computer ordevice, etc.). Information (e.g., user, system, facility, patient and/ordoctor information, etc.) may be pre-stored on the information deviceand/or entered by a user via system, interface or communication deviceinput devices (e.g., keypad, etc.). The recordation or collection ofinformation may occur automatically or via user entered information(e.g., start, stop and/or record keys). The system interface and/orcommunications device may implement or be implemented by the temperaturecontroller. The monitoring sensors may be coupled to the temperaturecontroller, report unit, system interface and/or communications deviceeither individually or in any combination or fashion.

The information device may be of any shape or size, may be implementedby any type of device including any type of memory or storage (e.g., amicroprocessor with memory, a chip, a floppy, magnetic or optical disk,CD-ROM, USB disk, smart card, etc.) and may contain any desiredinformation. The information device may include any pre-storedinformation and may be coupled to the thermal treatment system, computersystem, system interface or computer interface via any conventional orother techniques (e.g., direct connection, infrared, RF transmission,cellular, Bluetooth, etc.). The system interface, communications deviceand/or computer interface may be disposed internal or external of therespective thermal treatment and computer systems. The system interfacemay further be in communication with a local or remote computer system(e.g., via network, cables, wireless transmission, etc.) to transfer andreceive information (without use or in addition to the computerinterface).

The system and computer interfaces may engage or receive the informationdevice in any fashion. The information device may include any storageand/or processing capabilities. For example, the information device mayperform the functions of the system interface, where the systeminterface in this case basically couples the information device to thethermal treatment system (e.g., temperature controller and/or sensors).The information device may include any degree of intelligence, where thefunctions of the system interface may be distributed in any fashionamong the system interface and information device. Further, theinformation device may include processing to generate desired reportsand displays for transfer to other devices (e.g., computer systems,monitors, etc.). The information device may be removable with respect tothe thermal treatment system, system interface and computer interfaceand may be transported between the devices in any fashion (e.g., theuser, mechanical devices, etc.).

Use of a medical item thermal treatment system can be authorized basedupon any single or combination of quantifiable authorized use parametersor metrics (e.g., a calendar/time period during which the medical itemthermal treatment system is authorized for use, a number ofwarming/cooling cycles for which the medical item thermal treatmentsystem is authorized for use, a number of medical items for which themedical item thermal treatment system is authorized for use, type of use(e.g., heating, cooling, heating and cooling, etc.), maximum number ofmedical items, power usage, etc.). Authorized use can be associated witha user authorization code or password that can include any number,character string, array, or combination thereof that is interpreted by amedical item thermal treatment system to authorize or limit use of anycapability or function supported by the medical item thermal treatmentsystem.

Operational or control parameters used to control operation of themedical item thermal treatment system can include any parameter that canbe used to specify an operational instruction or performancecharacteristic (e.g., a user access code, type of medical item accepted,a desired temperature for medical items, a maximum duration that amedical item (e.g., IV solution, blood, etc.) is allowed to remain inthe thermal treatment system, time and/or temperature thresholds to beused in controlling alarms, log event definitions, timeouts, timerperiods, various threshold values, log messages, storage destinations,etc.). Temperature profiles can be used as control parameters to controlthe rate of temperature increase/decrease and manner of maintaining thetemperature of any medical item. Alert thresholds can be used as controlparameters to control the issuance of alarms and/or to initiate aresponse (e.g., storing critical information, disabling awarming/cooling unit, etc.). The alert thresholds may be within anydesired range of an alert condition (e.g., temperature, exhaustion ofuse, etc.). The systems may include any type of visual and/or audioalarms (e.g., lights, beeps, flashes, synthesized voice, etc.) disposedat any suitable locations. Data collection instructions can be used ascontrol parameters to control what sensor information is stored, theformat in which it is stored, how often the information is polled and/orstored, and/or where information is to be stored. Display parameters canbe used as control parameters to control the content and arrangement ofgenerated displays and reports. Alternatively, the thermal treatmentsystems may receive the usage and control parameters in any desiredfashion (e.g., from a remote or local computer or other device, fromuser entry via input devices, etc.).

Displays and reports can be generated by any number of local and/orremote devices with access to the collected or stored thermal treatmentsystem information. Displays and reports can be generated by any numberof special purpose or generic display and report generators. A generateddisplay or report can be presented to a user via the same device thatgenerates the display or report and/or at one or more locally orremotely located display or printing devices. The displays and reportsmay be arranged in any fashion and include any desired information.Date, time and other display or report information may be in any desiredformat (e.g., month, day and year, hours and minutes, text, numeric,icons, etc.). The display or report information may be arranged and/orpresented (e.g., printed, displayed, etc.) in any desired formats (e.g.,text, charts, graphs, columns, rows, tables, etc.) and in any order orarrangement. The graph may include any quantity of axes each associatedwith any desired information (e.g., time, temperature, etc.) in anydesired scales or units (e.g., Celsius, Fahrenheit, etc.). The graphsmay utilize any types of symbols or characters (e.g., dots, diamonds,dashes, alphanumeric characters, punctuation symbols, etc.) to indicatepoints on the graph. The graphs may indicate time, temperature or events(e.g., removal of solution, etc.) in any fashion. The displays andreports may provide information (e.g., temperature, etc.) measured orcollected at any desired preset or user specified time intervals (e.g.,hours, minutes, seconds, etc.). The time intervals may be specified by auser via any input devices (e.g., temperature controller, systeminterface and/or communications device input devices (e.g., buttons,keys, etc.), remote or local computer, etc.). The display, report and/orinformation may alternatively be stored in a local or remote database ormemory device (e.g., local memory, removable memory, etc.) for laterretrieval. The displays and reports may include a pre-arranged format ormay be programmable or selected by a user via temperature controller,system interface and/or communications device input devices. Theinformation displayed may be selected via temperature controller, systeminterface and/or communications device input devices, or the display mayinclude display controls (e.g., buttons, keys, etc.).

The external printer may be implemented by any conventional or otherprinting device, may be local or remote, may serve any quantity ofsystems or other devices, and may produce displays and/or reports on anydesired medium (e.g., paper, labels, etc.). The displays and reports maybe printed and/or displayed concurrently with system operation asdisplay and report data is collected or at any specific time or inresponse to user entered information (e.g., a print command or key). Thedisplay and/or report may be printed at any desired time before, duringor after system use. The system and/or information device may downloador transfer information to any desired device (e.g., PDA, computer,another system, etc.) at any specific time or in response to userentered information (e.g., transmit command or key). The system mayfurther be networked to enable retrieval of information from a stationcoupled to the network. The printer and displays may be disposed at anysuitable locations on or remote from the system. Alternatively, thesystem may be implemented to generate displays and/or reports withoutthe printer and/or display. Any desired information may be transmittedbetween the system components (e.g., temperature controller, system andcomputer interfaces, communications device, information device, computerand server systems, printer, displays, etc.) via any conventional orother medium or protocols (e.g., hardwire, wireless, network, etc.).

The computer systems and server systems may be implemented by any typeof personal or other computer or processing system having any suitableplatform or operating system. The computer system may include anycommercially available operating system (e.g., Windows, OS/2, Unix,Linux, DOS, etc.), any commercially available and/or custom software(e.g., communications software, display and/or report generationsoftware, etc.) and any types of input devices (e.g., keyboard, mouse,microphone, voice recognition, etc.). The information stores may beimplemented by any conventional database or other storage structures(e.g., files, data structures, tables, etc.) or devices and may includeinformation stored in any number of files using any file format.

Software for the system devices (e.g., temperature controller, systeminterface, communications device, etc.) may be implemented in anydesired computer language and could be developed by one of ordinaryskill in the computer arts based on the functional descriptionscontained herein and the flow charts illustrated in the drawings. Thetemperature controller, system interface and/or communications devicemay alternatively be implemented by any type of hardware and/or otherprocessing circuitry, and may be available pre-programmed for immediateuse. The various functions of the temperature controller, systeminterface, computer interface and communications device may bedistributed in any manner among any quantity of software or hardwaremodules, computer systems, processors and/or circuitry. Further, anyreferences herein of software performing various functions generallyrefer to computer systems or processors performing those functions undersoftware control. The computer system may alternatively be implementedby hardware or other processing circuitry. The various functions of thepresent invention usage control may be distributed in any manner amongany quantity (e.g., one or more) of hardware and/or software modules orunits, computer or processing systems or circuitry, where the computeror processing systems may be disposed locally or remotely of each otherand communicate via any suitable communications medium (e.g., LAN, WAN,Intranet, Internet, hardwire, modem connection, wireless, etc.). Thesoftware and/or processes described above and illustrated in the flowcharts and diagrams may be modified in any manner that accomplishes thefunctions described herein.

Thermal treatment system 100 may be a stand-alone system or may becoupled to any number of workstation computers, server computers or datastorage devices via any communications medium (e.g., network, modem,direct connection, etc.). Authorized use and control parameters can betransferred via a communications network or via transportable storagedevices (e.g., floppy disk, CD ROM, DVD, zip drive disk, etc.).

Software used to access and display medical item thermal treatmentsystem information bases may be installed upon local or remote devicesand executed on a computer system in any conventional or other manner(e.g., an install program, copying files, entering an execute command,etc.). The functions associated with the present invention (e.g.,storing/retrieving monitored information, updating authorized use and/orcontrol parameters, etc.) may be performed on any quantity of computersor other processing systems. Further, the specific functions may beassigned to one or more of the computer systems in any desired fashion.

A user may interact with the medical item thermal treatment system andinformation device (e.g., related monitored/logged data, authorized useand control parameters, etc.) via any style of user interface (e.g., acommand line interface, a menu, a database interface, graphical userinterface, web site, etc.) on a local or remote computer or serversystem. The user interface may include any desired information arrangedin any format or fashion. Access for information retrieval and/orprocessing may be controlled by any conventional or other techniques(e.g., accounts, subscriptions, passwords, identifications, etc.).Interfaces used can be commercially available interfaces or developedespecially for use in connection with a medical item thermal treatmentsystem and/or medical item thermal treatment system information base.

Thermal treatment system 100 can be implemented by any number ofcontrollers, modules and/or units and is not limited to the architecturedescribed above. Payment for use of the medical item thermal treatmentsystem may be arranged in any fashion (e.g., telephone transaction,electronic transaction, billings by mail, online via a website or localor remote computer or server system, etc.) with a service provider orother party.

Temperature control system 700 and corresponding components may be ofany size or shape and may be constructed of any suitable materials. Thecontroller, fuses, power switches and labels may be disposed on thesystem at any suitable locations. The system may include any quantity ofeach component, while the components (e.g., cabinet, circuitry, drawers,etc.) may be arranged in any fashion. The temperature control system mayinclude any quantity (e.g., at least one) of drawers with each drawerhaving any quantity (e.g., at least one) of sub-compartments. Thedrawers may be of any size or shape and may be constructed of anysuitable materials. The drawers may include any conventional or otherhandle disposed at any location, and may include any conventional orother pivoting or sliding mechanisms to facilitate placement and removalof drawers and items within the systems. The drawer sub-compartments maybe of any quantity, size or shape, while the drawers andsub-compartments may each contain any quantity of any types of medicalitems. The drawers may include a window of any shape or size, or beimplemented without a window. The window may include any type oftransparent or translucent material, and may be defined at any suitablelocations on the drawer, door or cabinet. Further, the drawers may beimplemented by any types of drawers that are capable of being placed andremoved within the system (e.g., substantially horizontal drawers, suchas those in common desks), while the system may include any quantity orcombination of different types of drawers. Moreover, the drawers,sub-compartments or other receptacles may be disposed within the cabinetinterior chambers on shelves or other structures for receiving themedical items.

The temperature sensor of system 700 may be implemented by anyconventional resistive or other type of temperature sensing device, andmay be disposed at any location on the drawer or cabinet interior. Theheating element may include any type of configuration covering theentirety or a portion of the drawer bottom wall (e.g., strips, bars,segments, include various openings, etc.). The heating element may beimplemented by any quantity of conventional or other types of heatingdevices (e.g., heating coils, conduction, convection, microwave or otherradiation, etc.), and may be disposed on the drawer at any locations.The heating element may include any type of conventional or otherconnector to facilitate heating element connections, and may be fastenedto the drawer via any conventional or other fastening techniques (e.g.,adhesives, brackets, etc.).

The control circuit components (e.g., power switch, relays, fuses,controller, power source, connection terminal, etc.) of system 700 maybe implemented by any quantity of any conventional or other electricalcomponents arranged in any fashion and performing the functionsdescribed above. The circuits may be disposed at any location on orwithin the housings and may be arranged in any fashion to controlheating of the drawers as described above. The relays may be implementedby any conventional solid state or other type of relay device.Similarly, the cut-out switch may be implemented by any conventional orother type of switching or power-limiting device. The fuses may beimplemented by any conventional or other fuses or limiting devicesconfigured for any desired current level, while the power switch may beimplemented by any conventional or other switching devices (e.g.,momentary, button, etc.) The system may include any quantity ofcontrollers, each controlling any quantity of drawers and accommodatingany quantity of set points. The controllers may each be implemented byany conventional or other microprocessor or controller. Software for thecontroller may be implemented in any desired computer language and couldbe developed by one of ordinary skill in the computer arts based on thefunctional descriptions contained herein. The controller mayalternatively be implemented by any type of hardware, software and/orother processing circuitry, and may be available pre-programmed forimmediate use. The various functions of the controller may bedistributed in any manner among any quantity of software modules,processors and/or circuitry. The algorithms and/or processes describedabove may be modified in any manner that accomplishes the functionsdescribed herein.

An intravenous pole and/or other equipment may be disposed at anylocations on the temperature control system. The pole and/or equipmentmay include any quantity of temperature control systems attached to thepole and/or equipment.

The temperature sensing strip may be implemented by any conventional orother types of temperature strips. The temperature sensing strip may beof any shape or size, may sense and/or display any desired temperaturesin any temperature scale (e.g., Fahrenheit, Celsius, etc.), and mayinclude any type of indicators (e.g., alphanumeric or other characters)arranged in any fashion and representing any temperature intervals orother information for any desired temperature range. The temperaturestrip may utilize any color scheme to illuminate the indicators or toindicate whether or not the solution temperature is within particularranges (e.g., above, within, or below a particular temperature range).Any quantity of temperature strips may be disposed on, attached to orformed integral with the system at any location having sufficientproximity to the item being measured via any conventional or otherfastening techniques. The system may be implemented with or without thetemperature sensing strips and/or labels.

The temperature sensing device may alternatively be implemented by anytype of temperature measuring device (e.g., preferably those capable ofmeasuring temperature without directly contacting container contents)and/or display. For example, the temperature sensing device may beimplemented by a temperature sensor in combination with a liquid crystal(LCD) or other display to measure and display item temperature. Thismechanism may include a battery and operate on direct current (DC)voltage, and/or include a power cord for connection to a common walloutlet jack and utilize alternating current (AC). Further, thetemperature sensing device may be implemented by a temperature sensorand a voice or speech synthesizer to indicate temperature or to specifythat an item is below or exceeds a predetermined temperature (e.g.,provide an audio indication, such as “too hot”, “too cold”, etc.).Moreover, the temperature sensing device may employ an analog orinfrared temperature sensor, or devices measuring temperature via sound,ultra-sonic or other waves, and convey that temperature in any of themanners described above.

The timer switch of system 700 may be implemented by any quantity of anytype of pressure or other switch and/or switch/sensor combination fordetecting the presence of a medical solution container or other item andactuating or disabling a circuit. The timer switch may include any typesof mechanical, electrical and/or chemical switching mechanisms or anycombinations thereof. The timer switch may be positioned at any locationwithin the system or sub-compartment to detect the presence of a medicalsolution container or other item.

System 700 may be used at any suitable locations (e.g., hospital orother medical facility, emergency medical or other vehicles, etc.) withany types of power sources (e.g., AC, DC, wall outlet jack, batteries,vehicle power system, etc.) to heat any quantity of any type of medicalsolution container or other item. The system may be mounted on orsupported by any type of support structure (e.g., wall, cart, table,floor, stand, etc.) via any conventional or other fastening mechanisms(e.g., brackets, hooks, welded, integral with system, etc.).

The timer of system 700 may be implemented by any conventional or othertiming or timer devices (e.g., processors, hardware or other circuitryand/or software, etc.). The timer may be disposed at any suitablelocations on or in proximity to the system. The timer may include anytype of conventional or other display (e.g., LED, LCD, monitor, etc.)integral with or remote from the timer or system.

The timer of system 700 may be initiated by the timer switch and/ormanually by a user via control or input devices (e.g., keys, buttons,etc.). The timer may increment or decrement time to measure elapsed timeand may measure and/or display the time in any desired format or timeunits (e.g., hours, minutes, seconds, etc.). The timer or system mayfurther include visual or audio alarms to notify a user when aparticular time interval expired, or disable heating upon expiration ofthat time interval. Further, the timer may be combined with orimplemented by the system controller. The timer reset line may perform areset based on any type of signal (e.g., high or low). The resettypically causes the display to display an initial value, preferablyzero, however the initial value may be set to any desired time or value.The system may include any quantity of timers, where the timers may eachbe associated with any quantity of sub-compartments and/or measureand/or display various time intervals (e.g., timer to measure residencetime within the system or drawer, timer to measure residence time withina sub-compartment, etc.).

The reset relay may be implemented by any conventional or other relaysor circuitry. The reset relay may provide any signal to the timer tofacilitate a reset. The power source may be implemented by anyconventional or other power source or circuitry and may provide anydesired power signal (e.g., 12V DC, AC, voltage, current, etc.).

System 700 may store residence time or any other information (e.g.,temperature, etc.) in memory in order to recover and maintain residencetime measurements and/or heating in the event of a power failure orother interruption of power (e.g., power off, etc.). The system mayfurther detect the temperature of a newly placed item prior tocommencing heating. If the item has a temperature above a thresholdindicating the item has been previously warmed, heating may be disabledand/or a user may be notified of the prior warming and/or that theresidence time does not include the prior warming.

The sub-compartments and timers may include any identifiers (e.g.,symbols, characters, numbers, etc.) to associate a sub-compartment witha corresponding timer. The sub-compartments and/or drawers may beindividually controlled to heat corresponding medical items to the sameor different desired temperatures.

The housings and housing components of systems 800, 900 (e.g., panels,walls, etc.) may be of any size, shape or configuration and may beconstructed of any suitable materials including, but not limited to,electrogalvanized steel. The housing components may be connected via anyconventional fastening techniques (e.g., welding, nuts and bolts, etc.).Any portion of the housings may be constructed of a transparentmaterial. The heating, storage and housing compartments may be of anyquantity, shape or size and may hold any quantity of medical solutioncontainers or other items (e.g., one or more containers or items). Thedoors may be of any quantity, shape or size, may be constructed of anysuitable materials, and may be connected to the housings at any suitablelocations in any fashion to pivot in any desired direction and/or manner(e.g. hinged doors, sliding doors, removable panel doors, etc.). The topwall or doors may be connected to the housing at any suitable locationsin any fashion to pivot in any desired direction and/or manner (e.g.hinged doors, sliding doors, removable panel doors, etc.). Further, thedoors and top wall may include a window of any size or shape, while thedoors, top wall and/or window may be constructed of any translucent,transparent or other materials. The doors and top wall may include anyquantity of any type of handle or latching mechanism disposed at anysuitable locations. The housing open portions may be of any shape orsize and may be disposed at any suitable locations. The housings mayinclude any types of openings, mechanisms, devices or other techniquesto provide access to the housing interior.

Systems 800, 900 may warm any quantity of any type of medical solutioncontainer or other item to any desired temperature. The controllers ofthese systems may be implemented by any conventional or othermicroprocessor or controller. Software for the controllers may beimplemented in any desired computer language and could be developed byone of ordinary skill in the computer arts based on the functionaldescriptions contained herein. The controllers may alternatively beimplemented by any type of hardware, software and/or other processingcircuitry, and may be available pre-programmed for immediate use. Thevarious functions of the controllers may be distributed in any manneramong any quantity of software modules, processors and/or circuitry. Thealgorithms and/or processes described above may be modified in anymanner that accomplishes the functions described herein.

The controllers may be disposed on or within the systems at any suitablelocations. The controllers may control the heater to any desiredtemperature. The controllers or systems may include any quantity of anytype of input device (e.g., keys, buttons, mouse, voice, touch screen,etc.) to facilitate entry of any desired temperatures or any otherinformation. The controllers may include or control any quantity of anytype of display of any shape or size to convey any desired information.The display may be integral with or detached from the controllers orsystems and may include an LED, LCD or monitor type display, indicatorlights, or any other mechanism for indicating desired and/or measuredtemperature or any other information. Further, the display may includeany type of buttons or data entry devices to program the controller inany manner. The controllers may employ any conventional or other controlalgorithms (e.g., fuzzy logic, PID, etc.). The systems may include anyquantity of controllers to accommodate any quantity of heatingassemblies, or a single controller may accommodate plural heatingassemblies.

The heating plate may be of any quantity, shape, size or configurationto heat a medical solution or other item. The heating plate may includeany quantity of conducting and/or non-conducting walls of any shape orsize and may be constructed of any suitable materials. The heater ofsystems 800, 900 may be implemented by any quantity of any conventionalheater or other heating device (e.g., conduction, convection, microwaveor other radiation, etc.). The heating plate may include any quantity ofheaters of any shape or size arranged in any configuration (e.g.,strips, annular, segments, etc.) and disposed at any suitable locationsfor applying heat. The heater may be attached to the heating plate viaany conventional or other fastening technique (e.g., pressure sensitiveor other adhesives, etc.). The systems may alternatively include anyquantity of heaters of any shape or size disposed at any suitablelocations on the heating plate or within the systems.

The temperature sensors of systems 800, 900 may be implemented by anyquantity of any type of conventional or other temperature measuringdevice (e.g., RTD, infrared, etc.) and may be disposed at any suitablelocations on the arm, heating plate or within the systems. The cut-outswitch may be implemented by any quantity of any type of conventional orother limiting device and may be utilized for any desired temperature orthreshold. The cut-out switch may be utilized in combination with theadditional temperature sensor to facilitate disablement of the heater inresponse to any desired temperature or temperature range. The cut-outswitch and/or additional sensor may be disposed at any locations on thearm, heating plate or within the systems and may measure the temperatureof any system objects (e.g., heating plate, medical item, heater, etc.).Alternatively, a single temperature sensor may be employed to facilitatecontrol of the heater in response to measured medical item and excessiveheater temperatures.

The limit switch of systems 800, 900 may be implemented by any quantityof any type of pressure or other switch and/or switch/sensor combinationfor detecting the presence of a medical solution container or other itemand actuating or disabling a circuit. The limit switch may include anytypes of mechanical, electrical and/or chemical switching mechanisms orany combinations thereof. The limit switch may be positioned at anylocation proximate the heating plate or within the systems to detect thepresence of a medical solution container or other item. The limit switchcomponents (e.g., housing, arm, support member, contact member, etc.)may be of any shape or size and may be constructed of any suitablematerials. The arm may support any quantity of any types of sensingdevices. The switching circuitry may include any conventional or othercircuitry or mechanical and/or electrical components that accommodatethe contact member to establish or remove a circuit connection (e.g.,open or close a circuit).

The control circuits of systems 800, 900 may utilize any conventional orother connectors or wiring to transfer power and other signals to systemcomponents. Further, the components of the control circuits (e.g., powerswitch, relay, fuses, controllers, boards, power sources, back light,connection terminal, etc.) may be implemented by any quantity of anyconventional or other electrical components arranged in any fashion andperforming the functions described above. The circuits may be disposedat any location on or within the housings and may be arranged in anyfashion. The fuses may be implemented by any conventional or other fusesor limiting devices configured for any desired current level. The powerswitch, controllers, displays, input devices and indicators may bedisposed at any suitable locations on or within the housings.

Systems 800, 900 may be used at any suitable locations (e.g., hospitalor other medical facility, emergency medical or other vehicles, etc.)with any types of power sources (e.g., AC, DC, wall outlet jack,batteries, vehicle power system, etc.) to heat any quantity of any typeof medical solution container or other item. The systems preferably heatitems to desired temperatures within the approximate range of 80° F.-150° F., but may be utilized to heat the items to any desiredtemperatures or temperature ranges.

Systems 800, 900 may be mounted on or supported by any type of supportstructure (e.g., wall, cart, table, floor, stand, etc.). The stand maybe of any type, shape or size, may be constructed of any suitablematerials and may be utilized with any of the above-described systems.The stand may be connected to the systems at any desired locations viaany conventional or other fastening mechanisms (e.g., brackets, hooks,welded, integral with system, etc.). The stand components (e.g., hub,post, legs, etc.) may be of any quantity, shape or size, may beconstructed of any suitable materials and may be arranged in any desiredfashion. The stand may include any quantity of any type of wheels orrollers disposed at any suitable locations to facilitate transport ofthe system.

The storage compartment and door window may be of any shape or size andmay be disposed at any suitable locations. The window may be constructedof any suitable materials (e.g., glass, plastic, etc.) and include anydesired degree of transparency.

The timer of systems 800, 900 may be implemented by any conventional orother timing or timer devices (e.g., processors, hardware or othercircuitry and/or software, etc.). The timer may be utilized with any ofthe above-described systems and may be disposed at any suitablelocations on or in proximity to the systems. The timer may include anytype of conventional or other display (e.g., LED, LCD, etc.) integralwith or remote from the timer or systems. The timer or heat controllermay be initiated by the limit switch and/or manually by a user viacontrol or input devices (e.g., keys, buttons, etc.) to initiate timemeasurement. The timer or heat controller may increment or decrementtime to measure elapsed time and may measure and/or display the time inany desired format or time units (e.g., hours, minutes, seconds, etc.).The systems may further include visual or audio alarms to notify a userwhen a particular time interval expired, or disable heating uponexpiration of that time interval. Further, a timer may be combined withor implemented by any of the above-described controllers. The timerreset line may perform a reset based on any type of signal (e.g., highor low). A time reset typically causes the timer or other display todisplay an initial value, preferably zero, however the initial value maybe set to any desired time or value. Further, a time reset mayfacilitate display of any type of indicator (e.g., reload or emptyindication, etc.) The systems may include any quantity of timers orcontrollers to measure and/or display various time intervals (e.g.,timer to measure residence time within the system or storagecompartment, timer to measure residence time on heating plate, etc.).

The various relays (e.g., time delay, reset, etc.) may be implemented byany conventional or other relays or circuitry. The reset relay mayprovide any signal to the timer to facilitate a reset. The time delayreset or heat controller may be set to provide any desired time delay inany desired time units (e.g., minutes, seconds, etc.). The power sourcesmay be implemented by any conventional or other power sources orcircuitry and may provide any desired power signal (e.g., 12V DC, AC,voltage, current, etc.).

The guides may be of any quantity, shape or size, and may be constructedof any suitable materials (e.g., foam, plastic, etc.). The guides may bedisposed in the system in any quantity and in any desired fashion. Theguide components (e.g., leg, foot, etc.) may be of any shape or size andmay be connected in any fashion (e.g., at any desired angle, etc.). Theguides may be configured in any fashion (e.g., without legs) for usewith the systems described above (e.g., with or without a storagecompartment) to align the medical item.

The trays may be of any quantity, shape or size, and may be constructedof any suitable materials. The trays may be oriented at any desiredangle and may be mounted within the system housing in any desiredfashion via any conventional or other mounting mechanisms (e.g., rails,brackets, ledges, etc.). System 900 may include any quantity of trays,with each tray including any quantity of heating assemblies. The traysmay include any quantity of dividers, where the dividers may be of anyshape or size. The heating assemblies may be placed adjacent each otheron a tray without dividers. Alternatively, any quantity of heatingplates may be formed within a continuous sheet of heat conductingmaterial.

The system controller may directly control any quantity of heatingassemblies without use of the heat controllers. The system controllermay further communicate in any fashion with the heat controllers via anysuitable protocols. The system controller may receive any desiredinformation from a user, transfer any desired information to the heatcontrollers and may utilize any quantity of any type of indicators(e.g., visual, audio, LEDs, display, etc.) to indicate system conditions(e.g., power on, attainment of set point temperature, etc.). The displaymay display any information arranged in any fashion. The heatingassemblies may include any identifiers (e.g., symbols, characters,numbers, etc.) to associate a heating assembly with displayedinformation.

The heat controllers may control any quantity of heating assemblies andmay transfer and receive any desired information from the systemcontroller. The heat controllers may store residence time or any otherinformation (e.g., temperature, etc.) in memory in order to recover andmaintain residence time measurements and/or heating in the event of apower failure or other interruption of power (e.g., power off, etc.).The heat controllers may further detect the temperature of a newlyplaced item prior to commencing heating. If the item has a temperatureabove a threshold indicating the item has been previously warmed,heating may be disabled and/or a user may be notified of the priorwarming and/or that the residence time does not include the priorwarming. The heat controllers may detect any conditions and provide theinformation to the system controller. The heat controller may illuminatethe assembly indicator when the item temperature is within any desiredrange of the set point temperature. The assembly indicator may bedisposed at any location on the heating assembly, housing or tray andmay be implemented by any visual (LED, etc.) or audio device. The heatcontrollers may communicate with the system controller synchronously orasynchronously and at any desired time or time intervals. The functionsof the system and heat controllers may be distributed in any fashionamong those controllers (e.g., the system may operate without one ofthose controllers). The heating assemblies may be individuallycontrolled to heat corresponding medical items to the same or differentdesired temperatures.

Systems 800, 900 and/or the limit switch may be responsive to aparticular weight of or pressure exerted by a medical item (e.g., toinitiate heating, residence time measurements, etc.). For example, thelimit switch may enter a closed state in response to a medical itemhaving at least a desired weight or exerting at least a certain pressureagainst the switch. This enables the system to accommodate anddiscriminate between particular medical items (e.g., a system forheating three liter medical solution bags does not operate for one litermedical solution bags).

The marking device may be powered by any conventional or other powersource (e.g., AC, DC, wall outlet jack, batteries, etc.). The markingdevice may be of any quantity, may be implemented by any conventional orother marking device and may be utilized in combination with anyquantity of thermal treatment or other systems. The marking device maybe implemented as a stand-alone device or may be attached to or integralwith the thermal treatment or other system. The marking device ispreferably disposed within the proximity of the thermal treatment orother system, but may be disposed in any fashion relative to thatsystem.

The marking device housing may be of any shape or size and may beconstructed of any suitable materials. The marking device may besecurable (either alone or in combination with the thermal treatment orother system) to any type of support structure (e.g., wall, pole, stand,etc.) via any conventional or other securing techniques (e.g., brackets,etc.). The marking device components (e.g., processor, switch, display,input devices, printing unit, etc.) may be disposed and arranged onand/or in the housing in any desired fashion. The marking area may bedisposed at any location on the housing and may be of any shape or sizeto accommodate marking of any desired items.

The marking device switch may be disposed in the marking area or at anyother locations suitable to engage the item and initiate marking. Themarking device processor may be implemented by any quantity of anyconventional or other microprocessor or controller (e.g., chip, card,processor, circuitry, etc.). The marking device may include any quantityof any desired input devices (e.g., buttons, keypad, voice recognition,touch screen, etc.) disposed at any locations. The marking device mayemploy any type of conventional or other sensor or switch to indicatethe presence of an item for marking. Alternatively, the marking devicemay include a marking key or button for manual control of marking by auser (e.g., the key is actuated by a user in response to properpositioning of the item for marking).

The marking device may mark any types of medical or other items (e.g.,solution containers or bags, cassettes, lines, labels, instruments,fabrics, cards, materials, paper products, etc.) at any locations on theitems. The items may be transported or presented to the marking deviceby a user for marking. Alternatively, the marking device may store itemstherein and provide to a user an item with time stamp information. Forexample, the marking device may store blank labels or labels pre-printedwith descriptive information. When a user actuates a marking device keyor button, the marking device retrieves a stored label and places thetime stamp information thereon. The label with time stamp information isprovided to the user for attachment to a medical item.

The marking device may maintain and/or provide any desired informationfor placement on an item (e.g., start date and time of solution or otheritem heating/cooling, the time interval the solution or other item washeated/cooled, the temperature the solution or other item attainedduring heating/cooling, temperature of the solution or other item whenthe solution was removed from the system, amount or quantity of solutionor other item residing, placed in or removed from the system, partial orcomplete history of time and solution or other item temperature measuredat any desired time intervals, facility information, patientinformation, doctor information, type of procedure, solutioninformation, type of instruments or other item being heated/cooled,amount or quantity of solution or other item being heated/cooled, etc.)from any desired sources (e.g., thermal treatment system, user, memorydevice, another computer or device, etc.). The processor may maintainthe time stamp information internally or utilize any desired externalcircuitry (e.g., a timer, memory, etc.). The marking device may furthermaintain the time stamp information provided to articles to provide areport of medical item or procedure activity for any desired timeinterval.

The time stamp information may be arranged in any fashion and includeany desired information. The date, time and other information may be inany desired format (e.g., month, day and year, hours and minutes, text,numeric, icons, etc.). The time stamp information may be arranged and/orpresented (e.g., printed, displayed, etc.) in any desired formats and inany order or arrangement. The time stamp information may alternativelybe stored in a local or remote database or memory device (e.g., localmemory, removable memory, etc.) for later retrieval. The printed ormarked time stamp information may include a pre-arranged format or maybe programmable or selected by a user via marking device input devices.The time stamp information may be placed at any suitable location on anitem. The marking device display may be of any quantity, shape or size,may be disposed at any location on or remote from the marking device,may be implemented by any conventional or other displays (e.g., LED,LCD, etc.) and may display any desired information. The informationdisplayed may be selected via marking device input devices, or thedisplay may include display controls (e.g., buttons, keys, etc.).

The marking device printing unit may be implemented by any conventionalor other printing or impression device and may transfer the time stampinformation on any desired medium (e.g., paper, labels, medical items,etc.). The time stamp information may be placed directly on the article(e.g., item or label) via any conventional or other techniques (e.g., aphysical impression on the article (with or without ink), a printedindicator by dot matrix, laser printing or thermal techniques, etc.).The marking device and thermal treatment system may include anyconventional or other communications device or module (e.g., modem,etc.) to communicate with each other or other devices. For example,placement of time stamp information on a medical item may enable themarking device to communicate with the thermal treatment system to startand/or cease operation. Further, the marking device may download ortransfer an electronic form of the time stamp information to any desireddevice (e.g., PDA, computer, another marking device, thermal treatmentsystem, etc.) at any specific time or in response to user enteredinformation (e.g., transmit command or key). The marking device mayfurther be networked to enable retrieval of information from a stationor other devices (e.g., thermal treatment system, another markingdevice, etc.) coupled to the network. Any desired information may betransmitted between the marking device components (e.g., processor,switch, display, input devices, printing unit, etc.) via anyconventional or other communications medium or protocols (e.g.,hardwire, wireless, network, etc.).

The label for the time stamp information may be of any size or shape andmay be of any type of printing material (e.g., paper, thermal paper,fabric, etc.). The label may include any quantity of areas or fields atany suitable locations to receive specific time stamp information fromthe marking device (e.g., entry time into the thermal treatment system,removal time, date, facility name, type of solution, etc.). The fieldsmay include any type of descriptive information. Alternatively, thelabels may be blank, where the marking device provides the time stampand descriptive information. The descriptive information may be providedpre-printed on the label or by the marking device in any combination.

The labels may be adhered to the medical item at any suitable locationsvia any conventional or other techniques (e.g., adhesive, fastener,self-adhesive label, etc.). The label adhesive may be sufficientlystrong to prevent removal of the label from the bag and/or labeltampering, or the strength of the label adhesive may enable a user toremove the label from the bag for attachment to other items (e.g.,patient or other chart or record, etc.). Alternatively, the medical itemmay include the label already attached and be presented to the markingdevice to receive the time stamp information. In addition, the medicalitem may include any descriptive information and/or fields and maydirectly receive the time stamp information from the marking device(e.g., via printing or impression techniques) at any desired locations.

The label may be any type of label enabling any quantity of time stampinformation to be placed thereon. Further, the label may include or bepartitioned into any quantity of individual sections, each of which mayreceive time stamp information at different instances and may beindividually adhesive. For example, a label may include or bepartitioned into two sections. The label is presented to or supplied bythe marking device, where a first section receives time stampinformation pertaining to insertion of a medical item into a thermaltreatment system. The label is adhered to a medical item (e.g., with thefirst section adhering to the medical item and the second section in anon-adhering state) prior to insertion of the medical item into thethermal treatment system. When the medical item is removed from thethermal treatment system, the medical item is transported to the markingdevice to enable the second section of the label (e.g., which is notadhered to the medical item) to be presented to the marking device toreceive time stamp information pertaining to removal of the medical itemfrom the thermal treatment system. The second label section issubsequently placed in an adhering state for adherence to the medicalitem.

Software for the marking device processor may be implemented in anydesired computer language and could be developed by one of ordinaryskill in the computer arts based on the functional descriptionscontained herein. The processor may alternatively be implemented by anytype of hardware and/or other processing circuitry, and may be availablepre-programmed for immediate use. The various functions of the processormay be distributed in any manner among any quantity of software modules,processors and/or circuitry. The algorithms and/or processes describedabove may be modified in any manner that accomplishes the functionsdescribed herein. Further, an item may be marked any quantity of timeswith time stamp information at any instances to provide a history ofitem activity and may include any quantity of labels. Moreover, an itemmay include time stamp information placed directly on the item, placedon a label adhered to the item, or placed on the item and label in anycombination.

The thermal treatment systems described above may be used at anysuitable locations (e.g., hospital or other medical facility, emergencymedical or other vehicles, etc.) with any types of power sources (e.g.,AC, DC, wall outlet jack, batteries, vehicle power system, etc.) tothermally treat any quantity of any type of medical solution containeror other item. The systems preferably heat items to desired temperatureswithin the approximate range of 80° F.-150° F., but may be utilized toheat and/or cool the items to any desired temperatures or temperatureranges.

It is to be understood that the terms “top”, “bottom”, “front”, “rear”,“side”, “height”, “width”, “length”, “upper”, “lower” and the like areused herein merely to describe points of reference and do not limit thepresent invention to any particular configuration or orientation.

From the foregoing description, it will be appreciated that theinvention makes available novel medical item thermal treatment systemsand method of monitoring medical items for compliance with prescribedrequirements, wherein medical items may be monitored for compliance withprescribed requirements from item manufacture through item use and/ordisposal.

Having described preferred embodiments of new and improved medical itemthermal treatment systems and method of monitoring medical items forcompliance with prescribed requirements, it is believed that othermodifications, variations and changes will be suggested to those skilledin the art in view of the teachings set forth herein. It is therefore tobe understood that all such variations, modifications and changes arebelieved to fall within the scope of the present invention as defined bythe appended claims.

1. A temperature control system for thermally treating medical items todesired temperatures comprising: a temperature control unit including: aunit housing; a thermal treatment unit disposed within said housing tothermally treat at least one medical item; a controller to facilitateentry of a desired temperature and to control a thermal output of saidthermal treatment unit to thermally treat said at least one medical itemto said entered desired temperature; and a usage control unit to confineoperational usage of said temperature control unit by a user forthermally treating said at least one medical item to be within anauthorized use interval for said user defined by usage parametersassociated with said user, wherein said usage control unit disablesoperation of said temperature control unit by said user for thermallytreating said at least one medical item outside said authorized useinterval associated with said user and said usage parameters include atleast one of a time interval for said operational usage of saidtemperature control unit to thermally treat said at least one medicalitem, a quantity of thermal cycles, a quantity of medical items tothermally treat, and a duration a medical item remains within saidsystem.
 2. The temperature control system of claim 1, wherein saidthermal treatment unit heats said at least one medical item.
 3. Thetemperature control system of claim 1, wherein said thermal treatmentunit cools said at least one medical item.
 4. The temperature controlsystem of claim 1, wherein said temperature control unit furtherincludes: at least one temperature sensor to measure a temperature of acorresponding medical item, wherein said controller controls saidthermal output of said thermal treatment unit to thermally treat said atleast one medical item to said entered desired temperature based on saidtemperature measured by said corresponding temperature sensor.
 5. Thetemperature control system of claim 4, wherein said temperature controlunit further includes: a timer to measure residence time of each medicalitem thermally treated by said thermal treatment unit.
 6. Thetemperature control system of claim 1 further including: an informationstorage device to store said usage parameters, wherein said informationstorage device is provided by said user to said temperature controlunit.
 7. The temperature control system of claim 6, wherein saidinformation storage device includes at least one of a card, a memorydevice, a removable storage device, an integrated circuit and a chip. 8.The temperature control system of claim 6, wherein said usage controlunit includes: a system interface to transfer information with saidinformation storage device.
 9. The temperature control system of claim8, wherein said system interface collects information pertaining to atleast one of medical item conditions, system conditions, time,corresponding temperature information for at least one medical item,patient information, user information, doctor information and facilityinformation.
 10. The temperature control system of claim 9, wherein saidsystem interface stores said collected information on said informationstorage device.
 11. The temperature control system of claim 10, whereinsaid information storage device is provided to a service provider toretrieve said stored information from said information storage deviceand generate a report for said user.
 12. The temperature control systemof claim 10 further including: an external interface to transferinformation with said information storage device; and an externalprocessing device coupled to said external interface to enable transferof information with said information storage device.
 13. The temperaturecontrol system of claim 12, wherein said external processing deviceenables an authorized user to perform at least one of retrieval ofinformation from said information storage device in the form of a reportand adjust said usage parameters stored on said information storagedevice to enable further use of said temperature control unit.
 14. Thetemperature control system of claim 12 further including: a serversystem in communication with said external processing device to receiveand store said information stored on said information storage device,wherein said server system includes a web site accessible by said userto perform at least one of retrieval of information from saidinformation storage device in the form of a report and adjust said usageparameters stored on said information storage device to enable furtheruse of said temperature control unit.
 15. The temperature control systemof claim 1, wherein said temperature control unit further includes: acommunications device to facilitate communications with an externaldevice and to collect information pertaining to at least one of medicalitem conditions, system conditions, time, corresponding temperatureinformation for at least one medical item, patient information, userinformation, doctor information and facility information.
 16. Thetemperature control system of claim 15, wherein said external deviceincludes a server system to transfer information with saidcommunications device and to store said collected information.
 17. Thetemperature control system of claim 16, wherein said server systemcommunicates with said communication device via a network.
 18. Thetemperature control system of claim 16, wherein said server systemincludes a web site accessible by said user via an end user device toperform at least one of retrieval of said collected information in theform of a report and adjustment of said usage parameters to enablefurther use of said temperature control system.
 19. The temperaturecontrol system of claim 16, wherein said communications device transferssaid collected information to said server system in real time to enablesaid user to access said transferred information via an end user deviceto remotely monitor a status of said temperature control unit.
 20. Thetemperature control system of claim 19, wherein said end user deviceprovides at least one alarm to indicate conditions exceeding prescribedrequirements.
 21. The temperature control system of claim 19, furtherincluding a plurality of said temperature control units, wherein saidcommunications device of each temperature control unit transfers saidcollected information to said server system in real time to enable saiduser to access said transferred information via an end user device toremotely monitor a status of said temperature control units.
 22. Atemperature control system for thermally treating medical items todesired temperatures comprising: a temperature control unit including: aunit housing; a thermal treatment unit disposed within said housing tothermally treat at least one medical item; a controller to facilitateentry of a desired temperature and to control a thermal output of saidthermal treatment unit to thermally treat said at least one medical itemto said entered desired temperature; and a usage control unit to controlusage of said temperature control unit in accordance with usageparameters associated with a user; an information storage device tostore said usage parameters, wherein said information storage device isprovided by said user to said temperature control unit and said usageparameters stored on said information storage device are adjusted by aservice provider to enable further use of said temperature control unit.23. A temperature control system for thermally treating medical items todesired temperatures comprising: a temperature control unit including: aunit housing; a thermal treatment unit disposed within said housing tothermally treat at least one medical item; a controller to facilitateentry of a desired temperature and to control a thermal output of saidthermal treatment unit to thermally treat said at least one medical itemto said entered desired temperature; and a usage control unit to controlusage of said temperature control unit in accordance with usageparameters associated with a user; an information storage device tostore said usage parameters, wherein said information storage device isprovided by said user to said temperature control unit; wherein saidusage control unit includes a system interface to transfer informationwith said information storage device, and wherein said system interfacedisables said controller in response to said usage parameters indicatingcompletion of authorized use of said temperature control unit.
 24. Atemperature control system for thermally treating medical items todesired temperatures comprising: a temperature control unit including: aunit housing; a thermal treatment unit disposed within said housing tothermally treat at least one medical item; a controller to facilitateentry of a desired temperature and to control a thermal output of saidthermal treatment unit to thermally treat said at least one medical itemto said entered desired temperature; and a usage control unit to controlusage of said temperature control unit in accordance with usageparameters associated with a user; an information storage device tostore said usage parameters, wherein said information storage device isprovided by said user to said temperature control unit; wherein saidusage control unit includes a system interface to transfer informationwith said information storage device, and wherein said system interfaceupdates said usage parameters in accordance with use of said temperaturecontrol unit by said user.
 25. The temperature control system of claim24, wherein said temperature control unit further includes: a display todisplay at least one of said updated usage parameters to inform saiduser of remaining authorized use of said temperature control unit.
 26. Asystem for confining operational use of a temperature control unit thatthermally treats medical items to desired temperatures to be within anauthorized use interval in accordance with usage parameters associatedwith a user and defining said authorized use interval, wherein operationof said temperature control unit by said user for thermally treating atleast one medical item is disabled outside said authorized use intervalassociated with said user, said system comprising: a server computersystem including a web site accessible by said user to modify saidauthorized use interval by adjusting said usage parameters to enablefurther use of said temperature control unit by said user, and whereinsaid usage parameters include at least one of a time interval for saidoperational usage of said temperature control unit to thermally treatsaid at least one medical item, a quantity of thermal cycles, a quantityof medical items to thermally treat, and a duration a medical itemremains within said temperature control unit.
 27. The system of claim 26further including: an information storage device to transfer informationwith said temperature control unit and store collected information; anexternal interface to transfer information with said information storagedevice; and an external processing device coupled to said externalinterface to enable transfer of information between said informationstorage device and said server computer system.
 28. The system of claim27, wherein said information storage device stores said usage parametersto control use of said temperature control unit.
 29. A system forcontrolling use of a temperature control unit that thermally treatsmedical items to desired temperatures in accordance with usageparameters associated with a user, said system comprising: a servercomputer system to receive and store information collected by saidtemperature control unit, wherein said server computer system includes aweb site accessible by said user to perform at least one of retrieval ofsaid collected information in the form of a report and adjustment ofsaid usage parameters to enable further use of said temperature controlunit, wherein said server computer system communicates with saidtemperature control unit to receive said collected information andadjust said usage parameters.
 30. The system of claim 29, wherein saidserver computer system communicates with said temperature control unitvia a network.
 31. The system of claim 29, wherein said temperaturecontrol unit transfers said collected information to said servercomputer system in real time to enable said user to access saidtransferred information via an end user device to remotely monitor astatus of said temperature control unit.
 32. A method of thermallytreating medical items to desired temperatures comprising: (a) receivingat least one medical item within a housing of a temperature control unitfor thermal treatment by a thermal treatment unit; (b) facilitatingentry of a desired temperature and controlling a thermal output of saidthermal treatment unit to thermally treat said at least one medical itemto said entered desired temperature; and (c) confining operational usageof said temperature control unit by a user for thermally treating saidat least one medical item to be within an authorized use interval forsaid user defined by usage parameters associated with said user, whereinoperation of said temperature control unit by said user for thermallytreating said at least one medical item is disabled outside saidauthorized use interval associated with said user and said usageparameters include at least one of a time interval for said operationalusage of said temperature control unit to thermally treat said at leastone medical item, a quantity of thermal cycles, a quantity of medicalitems to thermally treat, and a duration a medical item remains withinsaid system.
 33. The method of claim 32, wherein step (a) furtherincludes: (a.1) heating said at least one medical item.
 34. The methodof claim 32, wherein step (a) further includes: (a.1) cooling said atleast one medical item.
 35. The method of claim 32, wherein step (b)further includes: (b.1) measuring a temperature of a correspondingmedical item and controlling said thermal output of said thermaltreatment unit to thermally treat said at least one medical item to saidentered desired temperature based on a corresponding measuredtemperature.
 36. The method of claim 35, wherein step (b) furtherincludes: (b.2) measuring residence time of each medical item thermallytreated by said thermal treatment unit.
 37. The method of claim 32,wherein step (c) further includes: (c.1) storing said usage parameterson an information storage device, wherein said information storagedevice is provided by said user to said temperature control unit. 38.The method of claim 37, wherein said information storage device includesat least one of a card, a memory device, a removable storage device, anintegrated circuit and a chip.
 39. The method of claim 37, wherein step(b) further includes: (b.1) collecting information pertaining to atleast one of medical item conditions, unit conditions, time,corresponding temperature information for at least one medical item,patient information, user information, doctor information and facilityinformation.
 40. The method of claim 39, wherein step (c) furtherincludes: (c.2) storing said collected information on said informationstorage device.
 41. The method of claim 40 further including: (d)providing said information storage device to a service provider toretrieve said stored information from said information storage deviceand generate a report for said user.
 42. The method of claim 40 furtherincluding: (d) performing, via an external processing device, at leastone of retrieval of information from said information storage device inthe form of a report and adjustment of said usage parameters stored onsaid information storage device to enable further use of saidtemperature control unit.
 43. The method of claim 40, wherein anexternal device transfers information with said information storagedevice and is coupled to a server system with a web site, and saidmethod further includes: (d) transferring said collected informationfrom said information storage device to said server system; and (e)performing, via said web site of said server system, at least one ofretrieval of said collected information from said server system in theform of a report and adjustment of said usage parameters stored on saidinformation storage device to enable further use of said temperaturecontrol unit.
 44. The method of claim 32, wherein step (b) furtherincludes: (b.1) collecting information pertaining to at least one ofmedical item conditions, unit conditions, time, correspondingtemperature information for at least one medical item, patientinformation, user information, doctor information and facilityinformation; and (b.2) storing said collected information on a serversystem in communication with said temperature control unit.
 45. Themethod of claim 44, wherein said server system communicates with saidtemperature control unit via a network.
 46. The method of claim 44,wherein said server system includes a web site accessible by said uservia an end user device, and said method further includes: (d)performing, via said web site of said server system, at least one ofretrieval of said collected information in the form of a report andadjustment of said usage parameters to enable further use of saidtemperature control system.
 47. The method of claim 44, wherein step(b.1) further includes: (b.1.1) transferring said collected informationto said server system in real time; and said method further includes:(d) accessing said transferred information via an end user device toremotely monitor a status of said temperature control unit.
 48. Themethod of claim 47, wherein step (d) further includes: (d.1) providingat least one alarm on said end user device to indicate conditionsexceeding prescribed requirements.
 49. A method of thermally treatingmedical items to desired temperatures comprising: (a) receiving at leastone medical item within a housing of a temperature control unit forthermal treatment by a thermal treatment unit; (b) facilitating entry ofa desired temperature and controlling a thermal output of said thermaltreatment unit to thermally treat said at least one medical item to saidentered desired temperature; and (c) controlling usage of saidtemperature control unit in accordance with usage parameters associatedwith a user, wherein step (c) further includes: (c.1) storing said usageparameters on an information storage device, wherein said informationstorage device is provided by said user to said temperature controlunit; and (c.2) adjusting said usage parameters by a service provider toenable further use of said temperature control unit.
 50. A method ofthermally treating medical items to desired temperatures comprising: (a)receiving at least one medical item within a housing of a temperaturecontrol unit for thermal treatment by a thermal treatment unit; (b)facilitating entry of a desired temperature and controlling a thermaloutput of said thermal treatment unit to thermally treat said at leastone medical item to said entered desired temperature; and (c)controlling usage of said temperature control unit in accordance withusage parameters associated with a user, wherein step (c) furtherincludes: (c.1) storing said usage parameters on an information storagedevice, wherein said information storage device is provided by said userto said temperature control unit; and (c.2) transferring informationwith said information storage device and disabling said temperaturecontrol unit in response to said usage parameters indicating completionof authorized use of said temperature control unit.
 51. A method ofthermally treating medical items to desired temperatures comprising: (a)receiving at least one medical item within a housing of a temperaturecontrol unit for thermal treatment by a thermal treatment unit; (b)facilitating entry of a desired temperature and controlling a thermaloutput of said thermal treatment unit to thermally treat said at leastone medical item to said entered desired temperature; and (c)controlling usage of said temperature control unit in accordance withusage parameters associated with a user, wherein step (c) furtherincludes: (c.1) storing said usage parameters on an information storagedevice, wherein said information storage device is provided by said userto said temperature control unit; and (c.2) updating said usageparameters in accordance with use of said temperature control unit bysaid user.
 52. The method of claim 51, wherein step (c) furtherincludes: (c.3) displaying at least one of said updated usage parametersto inform said user of remaining authorized use of said temperaturecontrol unit.
 53. A method of confining operational use of a temperaturecontrol unit that thermally treats medical items to desired temperaturesto be within an authorized use interval in accordance with usageparameters associated with a user and defining said authorized useinterval, wherein operation of said temperature control unit by saiduser for thermally treating at least one medical item is disabledoutside said authorized use interval associated with said user, saidmethod comprising: (a) receiving and storing information collected bysaid temperature control unit on a server computer system including aweb site accessible by said user; and (b) modifying said authorized useinterval by adjusting said usage parameters, via said web site, toenable further use of said temperature control unit by said user,wherein said usage parameters include at least one of a time intervalfor said operational usage of said temperature control unit to thermallytreat said at least one medical item, a quantity of thermal cycles, aquantity of medical items to thermally treat, and a duration a medicalitem remains within said temperature control unit.
 54. The method ofclaim 53, wherein step (a) further includes: (a.1) storing saidcollected information on an information storage device; (a.2)transferring information between said information storage device andsaid temperature control unit; and (a.3) transferring informationbetween said information storage device and said server computer system.55. The method of claim 54, wherein step (a.1) further includes: (a.1.1)storing said usage parameters on said information storage device tocontrol use of said temperature control unit.
 56. A method ofcontrolling use of a temperature control unit that thermally treatsmedical items to desired temperatures in accordance with usageparameters associated with a user, said method comprising: (a) receivingand storing information collected by said temperature control unit on aserver computer system including a web site accessible by said user,wherein said server computer system conununicates with said temperaturecontrol unit, and step (a) further includes: (a.1) receiving saidcollected information from said temperature control unit and adjustingsaid usage parameters via said server computer system; (b) performing,via said web site, at least one of retrieval of said collectedinformation in the form of a report and adjustment of said usageparameters to enable further use of said temperature control unit. 57.The method of claim 56, wherein said server computer system communicateswith said temperature control unit via a network.
 58. The method ofclaim 56, wherein step (a.1) further includes: (a.1.1) transferring saidcollected information from said temperature control unit to said servercomputer system in real time; and said method further includes: (c)accessing said transferred information via an end user device toremotely monitor a status of said temperature control unit.
 59. A systemfor controlling usage of a medical device comprising: a medical device;and a usage control unit to confine operational usage of said medicaldevice by a user to be within an authorized use interval for said userdefined by usage parameters associated with said user, wherein saidusage control unit disables operation of said medical device by saiduser outside said authorized use interval associated with said user andsaid usage parameters include at least one of a time interval for saidoperational usage of said medical device and a quantity of operationalcycles.
 60. The system of claim 59, wherein said medical device collectsinformation pertaining to at least one of system conditions, time,patient information, user information, doctor information and facilityinformation.
 61. The system of claim 60 further including: aninformation storage device to store at least one of said usageparameters and said collected information, wherein said informationstorage device is provided by said user to said medical device.
 62. Thesystem of claim 61, wherein said information storage device includes atleast one of a card, a memory device, a removable storage device, anintegrated circuit and a chip.
 63. The system of claim 61, wherein saidinformation storage device is provided to a service provider to retrievesaid stored information from said information storage device andgenerate a report for said user.
 64. The system of claim 60 furtherincluding: a server computer system to receive and store said collectedinformation, wherein said server computer system includes a web siteaccessible by said user to perform at least one of retrieval of saidcollected information in the form of a report and adjustment of saidusage parameters to enable further use of said medical device.
 65. Amethod of controlling use of a medical device comprising: (a) confiningoperational usage of said medical device by a user to be within anauthorized use interval for said user defined by usage parametersassociated with said user, wherein operation of said medical device bysaid user is disabled outside said authorized use interval associatedwith said user and said usage parameters include at least one of a timeinterval for said operational usage of said medical device and aquantity of operational cycles.
 66. The method of claim 65, wherein step(a) further includes: (a.1) collecting information, via said medicaldevice, pertaining to at least one of system conditions, time, patientinformation, user information, doctor information and facilityinformation.
 67. The method of claim 66, wherein step (a) furtherincludes: (a.2) storing at least one of said usage parameters and saidcollected information on an information storage device, wherein saidinformation storage device is provided by said user to said medicaldevice.
 68. The method of claim 67, wherein said information storagedevice includes at least one of a card, a memory device, a removablestorage device, an integrated circuit and a chip.
 69. The method ofclaim 67, wherein step (a) further includes: (a.3) providing saidinformation storage device to a service provider to retrieve said storedinformation from said information storage device and generate a reportfor said user.
 70. The method of claim 66, wherein step (a) furtherincludes: (a.2) receiving and storing said collected information on aserver computer system, wherein said server computer system includes aweb site accessible by said user; and (a.3) performing, via said website, at least one of retrieval of said collected information in theform of a report and adjustment of said usage parameters to enablefurther use of said medical device.
 71. The method of claim 65, whereinstep (a) further includes: (a.1) leasing said medical device to saiduser, wherein said usage parameters include values to control use ofsaid medical device in accordance with an associated leasingarrangement.
 72. The method of claim 65, wherein step (a) furtherincludes: (a.1) renting said medical device to said user, wherein saidusage parameters include values to control use of said medical device inaccordance with an associated rental arrangement.